Intradialytic HypertensionNCT05430438
Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension
A study testing dialysis with low dialysate sodium concentration and dialysis with standard dialysate sodium concentration in people with Intradialytic Hypertension and End Stage Kidney Disease, run by Aristotle University Of Thessaloniki at 4 sites in 2 countries.
Trial summary
Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypertension, End Stage Kidney Disease
- What is being tested?
- dialysis with low dialysate sodium concentration and dialysis with standard dialysate sodium concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jun 2022to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ESKD individuals treated with a standard thrice weekly hemodialysis schedule for at least 3 months
- Patients with intradialytic hypertension, defined as SBP rise ≥10 mmHg from pre- to post-dialysis in at least 4 out of 6 consecutive sessions
- Patients that are considered clinically euvolemic
- Ability to provide informed written consent
Who cannot join
- Post-dialysis SBP <130 mmHg in at least 4 out of 6 consecutive sessions during the 2-week selection period, prior to study entry
- Previous non-functional arteriovenous fistula in the contralateral brachial arm area of the one used for vascular access that could interfere with proper ambulatory BP recording
- Patients with contraindications to receive the intervention (low dialysate sodium), i.e patients with frequent intradialytic hypotension episodes requiring intervention with fluid administration
- Pre-dialysis serum sodium <130 or >142 mEq/L at recruitment
- Modification of dry weight or antihypertensive treatment during one month before study initiation
- History of seizures or disequilibrium syndrome
- Hospitalization for any cause during one month before study initiation
- History of malignancy or any other condition with poor prognosis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Greece3 sites
Frontis Dialysis Center
Athens, 18757
Therapeutiki Dialysis Unit
Thessaloniki, 56532
Aristotle University of Thessaloniki
Thessaloniki
About this study
Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.
Read the detailed description
This is an interventional randomized crossover study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, adult patients (>18 years) with end stage kidney disease (ESKD) being treated with hemodialysis (HD) (on standard thrice-weekly HD treatment) for at least 3 months with intradialytic hypertension, fulfilling the inclusion/exclusion criteria were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.
Patients will be assessed for eligibility during the selection process (records of peridialytic BP measurements of the previous 2-week period will be assessed). Patients will be instructed to arrive to the Dialysis unit 30 min to 1 hour prior to their scheduled dialysis session, on 3 different dialysis days. Baseline evaluation of participants includes the recording of demographics and anthropometric characteristics, medical history, comorbidities, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. At baseline evaluation patients' hydration status will be assessed with lung ultrasound, while peridialytic BP and BP over the intradialytic period will be assessed with the Mobil-O-Graph device (IEM, Stolberg, Germany). The study includes two treatment periods (low vs standard dialysate sodium) with washout period of 2 weeks between them. Patients will be randomized to 2 groups, which will receive the intervention in the opposite order. Block randomisation will be used to determine treatment order based on a computer-generated randomization list. The first group (A) will undergo dialysis with low dialysate sodium (137 mEq/L) for 4 sessions starting from a mid-week session (i.e Wednesday or Thursday). Immediately before the beginning of the 4th session patients will be assessed with lung ultrasound and the 48h ambulatory BP monitoring will start using the Mobil-O-Graph device. After a 2-week washout period this group (A) will undergo dialysis with standard dialysate sodium (140 mEq/L) for 4 sessions and at the start of the 4th session, again, patients will be assessed with lung ultrasound and the 48h ABPM will begin. The second group will undergo dialysis first with standard dialysate sodium (140 mEq/L) for 4 sessions and then, after the 2-week washout period, with low dialysate sodium (137 mEq/L) for 4 sessions, with similar evaluations at the end of each intervention. Patients will not be aware of the order in which they will receive the 2 different dialysate sodium concentrations.
- Being tested
- dialysis with low dialysate sodium concentration, dialysis with standard dialysate sodium concentration
- Keywords
- Intradialytic Hypertension, Dialysis, ESKD, Dialysate sodium
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis with low dialysate sodium concentrationOther
Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 137 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity
dialysis with standard dialysate sodium concentrationOther
Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 140 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will undergo dialysis (4 sessions) with low dialysate sodium (137 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with standard dialysis sodium (140 mEq/L). Receives: Other: dialysis with low dialysate sodium concentration; Other: dialysis with standard dialysate sodium concentration |
| Group B | Experimental | Patients will undergo dialysis (4 sessions) with standard dialysate sodium (140 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with low dialysis sodium (137 mEq/L). Receives: Other: dialysis with low dialysate sodium concentration; Other: dialysis with standard dialysate sodium concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
Secondary outcomes (28)
The difference in 48h ambulatory diastolic blood pressure (DBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in intradialytic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in pre-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in post-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in ambulatory aortic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation index (AIx) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation index corrected for heart rate (AIx75) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation pressure (AP) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory arterial stiffness between low and standard dialysate sodium in patients with intradialytic hypertension
Ambulatory arterial stiffness will be assessed by ambulatory pulse wave velocity (PWV), as recorded with the Mobil-O-Graph device
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP standard deviation (SD) between low and standard dialysate sodium in patients with intradialytic hypertension
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP weighted SD (wSD) between low and standard dialysate sodium in patients with intradialytic hypertension
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP coefficient of variation (CV) between low and standard dialysate sodium in patients with intradialytic hypertension
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP average real variability (ARV) between low and standard dialysate sodium in patients with intradialytic hypertension
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
Measured: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in pre-dialysis body weight between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in interdialytic weight gain (IDWG) between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in hydration status (b-lines) assessed by lung ultrasound between low and standard dialysate sodium in patients with intradialytic hypertension
Measured: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for intradialytic SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for post-dialysis SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis body weight.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for IDWG.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for hydration status (b-lines).
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for intradialytic SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for pre-dialysis SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for post-dialysis SBP/DBP.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for pre-dialysis body weight.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for IDWG.
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for hydration status (b-lines).
Measured: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2022
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypertensionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fotini Iatridi, Aristotle University Of Thessaloniki
- Investigators
- Pantelis Sarafidis, Prof, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430438
- Sponsor's protocol ID
- ΔΔ4954
- Status last verified
- Sep 2023
- First submitted
- 9 Jun 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Georgianos PI, Sarafidis PA, Zoccali C. Intradialysis Hypertension in End-Stage Renal Disease Patients: Clinical Epidemiology, Pathogenesis, and Treatment. Hypertension. 2015 Sep;66(3):456-63. doi: 10.1161/HYPERTENSIONAHA.115.05858. Epub 2015 Jul 6. No abstract available.
PubMed 26150436Inrig JK, Molina C, D'Silva K, Kim C, Van Buren P, Allen JD, Toto R. Effect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study. Am J Kidney Dis. 2015 Mar;65(3):464-73. doi: 10.1053/j.ajkd.2014.10.021. Epub 2014 Dec 17.
PubMed 25530107Nair SV, Balasubramanian K, Ramasamy A, Thamizhselvam H, Gharia S, Periasamy S. Effect of low dialysate sodium in the management of intradialytic hypertension in maintenance hemodialysis patients: A single-center Indian experience. Hemodial Int. 2021 Jul;25(3):399-406. doi: 10.1111/hdi.12921. Epub 2021 Mar 18.
PubMed 33733579Bikos A, Angeloudi E, Memmos E, Loutradis C, Karpetas A, Ginikopoulou E, Panagoutsos S, Pasadakis P, Liakopoulos V, Papagianni A, Sarafidis P. A Comparative Study of Short-Term Blood Pressure Variability in Hemodialysis Patients with and without Intradialytic Hypertension. Am J Nephrol. 2018;48(4):295-305. doi: 10.1159/000493989. Epub 2018 Oct 22.
PubMed 30347395Agarwal R, Light RP. Intradialytic hypertension is a marker of volume excess. Nephrol Dial Transplant. 2010 Oct;25(10):3355-61. doi: 10.1093/ndt/gfq210. Epub 2010 Apr 16.
PubMed 20400448Robberechts T, Allamani M, Galloo X, Wissing KM, Van Der Niepen P. Individualized Isonatremic and Hyponatremic Dialysate Improves Blood Pressure in Patients with Intradialytic Hypertension: A Prospective Cross-Over Study with 24-h Ambulatory Blood Pressure Monitoring. Open Journal of Nephrology 2020; 10:144-157
Bikos A, Loutradis C, Angeloudi E, Karpetas A, Raptis V, Kalaitzidis R, Panagoutsos S, Pasadakis P, Balaskas I, Liakopoulos V, Papagianni A, Sarafidis PA. The effects of nebivolol and irbesartan on postdialysis and ambulatory blood pressure in patients with intradialytic hypertension: a randomized cross-over study. J Hypertens. 2019 Feb;37(2):432-442. doi: 10.1097/HJH.0000000000001891.
PubMed 30063644Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PubMed 39498822Iatridi F, Malandris K, Ekart R, Xagas E, Karpetas A, Theodorakopoulou MP, Karagiannidis A, Georgiou A, Papagianni A, Sarafidis P. Low dialysate sodium and 48-h ambulatory blood pressure in patients with intradialytic hypertension: a randomized crossover study. Nephrol Dial Transplant. 2024 Oct 30;39(11):1900-1910. doi: 10.1093/ndt/gfae104.
PubMed 38710537
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension
- ClinicalTrials.gov ID
- NCT05430438
- Acronym / sponsor ID
- ΔΔ4954
- Keywords
- Intradialytic Hypertension, Dialysis, ESKD, Dialysate sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.
Detailed description
This is an interventional randomized crossover study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, adult patients (>18 years) with end stage kidney disease (ESKD) being treated with hemodialysis (HD) (on standard thrice-weekly HD treatment) for at least 3 months with intradialytic hypertension, fulfilling the inclusion/exclusion criteria were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.
Patients will be assessed for eligibility during the selection process (records of peridialytic BP measurements of the previous 2-week period will be assessed). Patients will be instructed to arrive to the Dialysis unit 30 min to 1 hour prior to their scheduled dialysis session, on 3 different dialysis days. Baseline evaluation of participants includes the recording of demographics and anthropometric characteristics, medical history, comorbidities, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. At baseline evaluation patients' hydration status will be assessed with lung ultrasound, while peridialytic BP and BP over the intradialytic period will be assessed with the Mobil-O-Graph device (IEM, Stolberg, Germany). The study includes two treatment periods (low vs standard dialysate sodium) with washout period of 2 weeks between them. Patients will be randomized to 2 groups, which will receive the intervention in the opposite order. Block randomisation will be used to determine treatment order based on a computer-generated randomization list. The first group (A) will undergo dialysis with low dialysate sodium (137 mEq/L) for 4 sessions starting from a mid-week session (i.e Wednesday or Thursday). Immediately before the beginning of the 4th session patients will be assessed with lung ultrasound and the 48h ambulatory BP monitoring will start using the Mobil-O-Graph device. After a 2-week washout period this group (A) will undergo dialysis with standard dialysate sodium (140 mEq/L) for 4 sessions and at the start of the 4th session, again, patients will be assessed with lung ultrasound and the 48h ABPM will begin. The second group will undergo dialysis first with standard dialysate sodium (140 mEq/L) for 4 sessions and then, after the 2-week washout period, with low dialysate sodium (137 mEq/L) for 4 sessions, with similar evaluations at the end of each intervention. Patients will not be aware of the order in which they will receive the 2 different dialysate sodium concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: dialysis with low dialysate sodium concentration, Other: dialysis with standard dialysate sodium concentrationPatients will undergo dialysis (4 sessions) with low dialysate sodium (137 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with standard dialysis sodium (140 mEq/L). |
| Group B | Experimental | Other: dialysis with low dialysate sodium concentration, Other: dialysis with standard dialysate sodium concentrationPatients will undergo dialysis (4 sessions) with standard dialysate sodium (140 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with low dialysis sodium (137 mEq/L). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ESKD individuals treated with a standard thrice weekly hemodialysis schedule for at least 3 months
- Patients with intradialytic hypertension, defined as SBP rise ≥10 mmHg from pre- to post-dialysis in at least 4 out of 6 consecutive sessions
- Patients that are considered clinically euvolemic
- Ability to provide informed written consent
Key exclusion criteria (8 listed)
- Post-dialysis SBP <130 mmHg in at least 4 out of 6 consecutive sessions during the 2-week selection period, prior to study entry
- Previous non-functional arteriovenous fistula in the contralateral brachial arm area of the one used for vascular access that could interfere with proper ambulatory BP recording
- Patients with contraindications to receive the intervention (low dialysate sodium), i.e patients with frequent intradialytic hypotension episodes requiring intervention with fluid administration
- Pre-dialysis serum sodium <130 or >142 mEq/L at recruitment
- Modification of dry weight or antihypertensive treatment during one month before study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dialysis with low dialysate sodium concentrationPatients will undergo 4 dialysis sessions with a dialysate sodium concentration of 137 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity | Other | Group A, Group B |
| dialysis with standard dialysate sodium concentrationPatients will undergo 4 dialysis sessions with a dialysate sodium concentration of 140 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity | Other | Group A, Group B |
Primary outcome
The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
28 secondary outcomes
The difference in 48h ambulatory diastolic blood pressure (DBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in intradialytic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in pre-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in post-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in ambulatory aortic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation index (AIx) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation index corrected for heart rate (AIx75) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory Augmentation pressure (AP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in ambulatory arterial stiffness between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP standard deviation (SD) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP weighted SD (wSD) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP coefficient of variation (CV) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in 48h ambulatory brachial SBP/DBP average real variability (ARV) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
The difference in pre-dialysis body weight between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in interdialytic weight gain (IDWG) between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference in hydration status (b-lines) assessed by lung ultrasound between low and standard dialysate sodium in patients with intradialytic hypertension
Time frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for intradialytic SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for post-dialysis SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis body weight.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for IDWG.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference (delta) between baseline and end-of-treatment values of each intervention for hydration status (b-lines).
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for intradialytic SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for pre-dialysis SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for post-dialysis SBP/DBP.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for pre-dialysis body weight.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for IDWG.
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
The difference between low and standard dialysate sodium in the delta for hydration status (b-lines).
Time frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 26150436Georgianos PI, Sarafidis PA, Zoccali C. Intradialysis Hypertension in End-Stage Renal Disease Patients: Clinical Epidemiology, Pathogenesis, and Treatment. Hypertension. 2015 Sep;66(3):456-63. doi: 10.1161/HYPERTENSIONAHA.115.05858. Epub 2015 Jul 6. No abstract available.
- Background: PubMed 25530107Inrig JK, Molina C, D'Silva K, Kim C, Van Buren P, Allen JD, Toto R. Effect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study. Am J Kidney Dis. 2015 Mar;65(3):464-73. doi: 10.1053/j.ajkd.2014.10.021. Epub 2014 Dec 17.
- Background: PubMed 33733579Nair SV, Balasubramanian K, Ramasamy A, Thamizhselvam H, Gharia S, Periasamy S. Effect of low dialysate sodium in the management of intradialytic hypertension in maintenance hemodialysis patients: A single-center Indian experience. Hemodial Int. 2021 Jul;25(3):399-406. doi: 10.1111/hdi.12921. Epub 2021 Mar 18.
- Background: PubMed 30347395Bikos A, Angeloudi E, Memmos E, Loutradis C, Karpetas A, Ginikopoulou E, Panagoutsos S, Pasadakis P, Liakopoulos V, Papagianni A, Sarafidis P. A Comparative Study of Short-Term Blood Pressure Variability in Hemodialysis Patients with and without Intradialytic Hypertension. Am J Nephrol. 2018;48(4):295-305. doi: 10.1159/000493989. Epub 2018 Oct 22.
- Background: PubMed 20400448Agarwal R, Light RP. Intradialytic hypertension is a marker of volume excess. Nephrol Dial Transplant. 2010 Oct;25(10):3355-61. doi: 10.1093/ndt/gfq210. Epub 2010 Apr 16.
- BackgroundRobberechts T, Allamani M, Galloo X, Wissing KM, Van Der Niepen P. Individualized Isonatremic and Hyponatremic Dialysate Improves Blood Pressure in Patients with Intradialytic Hypertension: A Prospective Cross-Over Study with 24-h Ambulatory Blood Pressure Monitoring. Open Journal of Nephrology 2020; 10:144-157
- Background: PubMed 30063644Bikos A, Loutradis C, Angeloudi E, Karpetas A, Raptis V, Kalaitzidis R, Panagoutsos S, Pasadakis P, Balaskas I, Liakopoulos V, Papagianni A, Sarafidis PA. The effects of nebivolol and irbesartan on postdialysis and ambulatory blood pressure in patients with intradialytic hypertension: a randomized cross-over study. J Hypertens. 2019 Feb;37(2):432-442. doi: 10.1097/HJH.0000000000001891.
- Derived from this study: PubMed 39498822Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
- Derived from this study: PubMed 38710537Iatridi F, Malandris K, Ekart R, Xagas E, Karpetas A, Theodorakopoulou MP, Karagiannidis A, Georgiou A, Papagianni A, Sarafidis P. Low dialysate sodium and 48-h ambulatory blood pressure in patients with intradialytic hypertension: a randomized crossover study. Nephrol Dial Transplant. 2024 Oct 30;39(11):1900-1910. doi: 10.1093/ndt/gfae104.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pantelis Sarafidis, Prof study director
Aristotle University Of Thessaloniki
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dialysis with low dialysate sodium concentration and dialysis with standard dialysate sodium concentration in people with Intradialytic Hypertension and End Stage Kidney Disease, run by Aristotle University Of Thessaloniki at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension (time frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430438, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.