Chronic Renal FailureNCT02621450
Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters
A study testing standart dialysis and low sodium dialysis in people with Chronic Renal Failure and Hypertension, run by Yuzuncu Yil University.
Trial summary
End stage renal disease (ESRD) is related with increased cardiovascular mortality and morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among hemodialysis (HD) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure, Hypertension
- What is being tested?
- standart dialysis and low sodium dialysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2016
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients with creatinine clearance less than 10 ml/min/1.73 m2 and under intermittent HD treatment for at least one year are included into the study.
Who cannot join
- Masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency -
About this study
Official title: The Effect of Low Sodium Dialysate on Ambulatory Blood Pressure Measurement Parameters in Patients Undergoing Hemodialysis
End stage renal disease (ESRD) is related with increased cardiovascular mortality and morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis treatment.
Methods: The study will be included 46 patients who had creatinine clearance levels less than 10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium dialysate for six months via computer-generated randomization.
Read the detailed description
Patient Selection The present study is a single-center, randomized controlled and double blinded trial. The patients going to enroll for this study had creatinine clearance less than 10 ml/min/1.73 m2 and had been on intermittent HD treatment for at least one year.
The exclusion criteria for the present study are masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency.
Sixty-four patients going to enroll for eligibility and after the initial assessment. Clinic and laboratory profiles of the patients including cause of renal disease, history of HT and antihypertensive treatments going to record by systematic review of the patient files. After the enrollment stage, the patients going to allocate low-sodium dialysate or standard sodium dialysate for 6 months via computer-generated randomization.
They going to dialyze three times a week with synthetic polysulfone (Hollow-fiber, Low Flux, KUF<20, 1.6 m2) membrane, each session lasting 4 hours with bicarbonate dialysate (with 33mmol/L concentration) and 300-350 ml/min blood-flow. .
Study protocol All patients going to assess before and 6 months after the study. Before initiating the study, all patients were dialyzed with 140 mEq/L sodium concentration. In the low-sodium dialysate group, the dialysate sodium concentration going to reduce from 140 to 137mEq/L. To eliminate the acute effects of hemodialysis on the parameters measured, baseline and end-of-study measurements going to perform in non-dialysis day, 24 hours after the mid-week session.
Ambulatory blood pressure measurement Ambulatory BP measurement during 24-hour going to perform using a Space Labs 90207 oscillometric method (Redmond, Washington, USA). The BP measurements going to perform automatically from non-fistula arm. The confirmation of the device going to check with the standard auscultator method in order to ensure that the changes in BP values between the two methods did not exceed +5 mm Hg.
The device going to set to achieve BP evaluation at 30-minute intervals during the night (11:00 PM to 07:00 AM) and at 20-minute intervals during the day (07:00 AM to 11:00 PM).
''Nocturnal dipping'' going to define as a decrease of greater than 10% (when compared with the daytime values) in the systolic or diastolic blood pressure at night. ''Non-nocturnal dipping'' going to define as a decrease of less than 10% (when compared with the daytime values) in the blood pressure parameters levels at night or did not decrease in the systolic or diastolic blood pressure at night
- Conditions
- Chronic Renal Failure, Hypertension
- Being tested
- standart dialysis, low sodium dialysis
- Keywords
- chronic renal failure, hypertension, ampulatory blood pressure
- Medical subject headings
- Kidney Failure, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standart dialysisBiological
dialysate sodium consentration 140 mEq
low sodium dialysisBiological
dialysate sodium consentration will be reducer from 140 mEq to 137 mEq
| Study group | Role | What they receive |
|---|---|---|
| standart dialysate | Placebo comparator | dialysate sodium 140 mEq/L Receives: Biological: standart dialysis |
| low sodium dialysate | Other | dialysate sodium will be reduced from 140 mEq/L to 137 mEq/L Receives: Biological: low sodium dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure measurement
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ali gümrükçüoğlu, Yuzuncu Yil University
- Investigators
- hasan ali gümrükçüoğlu, Principal investigator, Yuzuncu Yil Univesty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621450
- Sponsor's protocol ID
- 2012-51
- Status last verified
- Nov 2015
- First submitted
- 21 Nov 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gumrukcuoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Gunes Y, Tuncer M. Effects of lowering dialysate sodium on carotid artery atherosclerosis and endothelial dysfunction in maintenance hemodialysis patients. Int Urol Nephrol. 2012 Dec;44(6):1833-9. doi: 10.1007/s11255-011-0117-5. Epub 2012 Jan 14.
PubMed 22246593Marshall 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 39498822
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Sodium Dialysate on Ambulatory Blood Pressure Measurement Parameters in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02621450
- Acronym / sponsor ID
- 2012-51
- Conditions
- Chronic Renal Failure, Hypertension
- Keywords
- chronic renal failure, hypertension, ampulatory blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- 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.
End stage renal disease (ESRD) is related with increased cardiovascular mortality and morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis treatment.
Methods: The study will be included 46 patients who had creatinine clearance levels less than 10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium dialysate for six months via computer-generated randomization.
Detailed description
Patient Selection The present study is a single-center, randomized controlled and double blinded trial. The patients going to enroll for this study had creatinine clearance less than 10 ml/min/1.73 m2 and had been on intermittent HD treatment for at least one year.
The exclusion criteria for the present study are masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency.
Sixty-four patients going to enroll for eligibility and after the initial assessment. Clinic and laboratory profiles of the patients including cause of renal disease, history of HT and antihypertensive treatments going to record by systematic review of the patient files. After the enrollment stage, the patients going to allocate low-sodium dialysate or standard sodium dialysate for 6 months via computer-generated randomization.
They going to dialyze three times a week with synthetic polysulfone (Hollow-fiber, Low Flux, KUF<20, 1.6 m2) membrane, each session lasting 4 hours with bicarbonate dialysate (with 33mmol/L concentration) and 300-350 ml/min blood-flow. .
Study protocol All patients going to assess before and 6 months after the study. Before initiating the study, all patients were dialyzed with 140 mEq/L sodium concentration. In the low-sodium dialysate group, the dialysate sodium concentration going to reduce from 140 to 137mEq/L. To eliminate the acute effects of hemodialysis on the parameters measured, baseline and end-of-study measurements going to perform in non-dialysis day, 24 hours after the mid-week session.
Ambulatory blood pressure measurement Ambulatory BP measurement during 24-hour going to perform using a Space Labs 90207 oscillometric method (Redmond, Washington, USA). The BP measurements going to perform automatically from non-fistula arm. The confirmation of the device going to check with the standard auscultator method in order to ensure that the changes in BP values between the two methods did not exceed +5 mm Hg.
The device going to set to achieve BP evaluation at 30-minute intervals during the night (11:00 PM to 07:00 AM) and at 20-minute intervals during the day (07:00 AM to 11:00 PM).
''Nocturnal dipping'' going to define as a decrease of greater than 10% (when compared with the daytime values) in the systolic or diastolic blood pressure at night. ''Non-nocturnal dipping'' going to define as a decrease of less than 10% (when compared with the daytime values) in the blood pressure parameters levels at night or did not decrease in the systolic or diastolic blood pressure at night
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standart dialysate | Placebo comparator | Biological: standart dialysisdialysate sodium 140 mEq/L |
| low sodium dialysate | Other | Biological: low sodium dialysisdialysate sodium will be reduced from 140 mEq/L to 137 mEq/L |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with creatinine clearance less than 10 ml/min/1.73 m2 and under intermittent HD treatment for at least one year are included into the study.
Key exclusion criteria (1 listed)
- Masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency -
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 |
|---|---|---|
| standart dialysisdialysate sodium consentration 140 mEq | Biological | standart dialysate |
| low sodium dialysisdialysate sodium consentration will be reducer from 140 mEq to 137 mEq | Biological | low sodium dialysate |
Primary outcome
Ambulatory blood pressure measurement
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 22246593Gumrukcuoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Gunes Y, Tuncer M. Effects of lowering dialysate sodium on carotid artery atherosclerosis and endothelial dysfunction in maintenance hemodialysis patients. Int Urol Nephrol. 2012 Dec;44(6):1833-9. doi: 10.1007/s11255-011-0117-5. Epub 2012 Jan 14.
- 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.
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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.
hasan ali gümrükçüoğlu principal investigator
Yuzuncu Yil Univesty
Questions about this trial
What is this clinical trial studying?
A study testing standart dialysis and low sodium dialysis in people with Chronic Renal Failure and Hypertension, run by Yuzuncu Yil University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Ambulatory blood pressure measurement (time frame: six months). 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 NCT02621450, which also lists 2 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 10 Dec 2015.