Patients With End Stage Renal Disease on HemodialysisNCT03578510
Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis
A study testing Standard hemodialysis in people with Patients With End Stage Renal Disease on Hemodialysis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients With End Stage Renal Disease on Hemodialysis
- What is being tested?
- Standard hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2012to 25 Mar 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- A thrice-weekly 4 hours hemodialysis schedule
- Dialysis on an arteriovenous fistula
- A usual interdialytic weight gain of ≥2.0 kg
Who cannot join
- Age<18 years
- Dialysis duration of <4 or >4 hours
- Dialysis frequency of <3 or >3 times a week
- Dialysis on a central venous catheter
- A usual interdialytic weight gain <2 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Lower Incidence of Intradialytic Hypotension During Hemocontrol Dialysis in Comparison With Standard Hemodialysis Attributable to Enhanced to Higher Plasma Vasopressin Levels or to Enhanced Sympathetic Activity and/or to Less Nitric Oxide Production
Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.
- Being tested
- Hemocontrol hemodialysis, Standard hemodialysis
- Keywords
- Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocontrol hemodialysisDevice
Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. The Hemocontrol system guides the patients' blood volume along a predefined ideal relative blood volume trajectory, by continuously adjusting ultrafiltration volume and dialysate sodium concentration.
Standard hemodialysisDevice
Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. During standard hemodialysis, a constant ultrafiltration rate and dialysate conductivity was used.
| Study group | Role | What they receive |
|---|---|---|
| SHD | Active comparator | Standard hemodialysis Receives: Device: Hemocontrol hemodialysis; Device: Standard hemodialysis |
| HHD | Experimental | Hemocontrol hemodialysis Receives: Device: Hemocontrol hemodialysis; Device: Standard hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma vasopressin levels
Plasma levels of the antidiuretic hormone, i.e. vasopressin
Measured: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.
Secondary outcomes (4)
Change in systolic and diastolic blood pressure in mmHg
Measured: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in heart rate in beats per minute
Measured: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in relative blood volume in %
Measured: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in plasma sodium levels in mmol/L
Measured: Before, after 30, 60, 120 and 180 minutes and after dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start17 Sep 2012
- Primary completion25 Mar 2013
- Study completion25 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With End Stage Renal Disease on HemodialysisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. C.F.M. Franssen, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578510
- Sponsor's protocol ID
- AVPII study
- Status last verified
- May 2023
- First submitted
- 12 Jun 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ettema EM, Kuipers J, van Faassen M, Groen H, van Roon AM, Lefrandt JD, Westerhuis R, Kema IP, van Goor H, Gansevoort RT, Gaillard CAJM, Franssen CFM. Effect of plasma sodium concentration on blood pressure regulators during hemodialysis: a randomized crossover study. BMC Nephrol. 2018 Aug 22;19(1):214. doi: 10.1186/s12882-018-0997-z.
PubMed 30134847
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Lower Incidence of Intradialytic Hypotension During Hemocontrol Dialysis in Comparison With Standard Hemodialysis Attributable to Enhanced to Higher Plasma Vasopressin Levels or to Enhanced Sympathetic Activity and/or to Less Nitric Oxide Production
- ClinicalTrials.gov ID
- NCT03578510
- Acronym / sponsor ID
- AVPII study
- Keywords
- Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 17 Sep 2012 (actual)
- Primary completion
- 25 Mar 2013 (actual)
- Study completion
- 25 Mar 2013 (actual)
- First posted
- 6 Jul 2018 (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 hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHD | Active comparator | Device: Hemocontrol hemodialysis, Device: Standard hemodialysisStandard hemodialysis |
| HHD | Experimental | Device: Hemocontrol hemodialysis, Device: Standard hemodialysisHemocontrol hemodialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- A thrice-weekly 4 hours hemodialysis schedule
- Dialysis on an arteriovenous fistula
- A usual interdialytic weight gain of ≥2.0 kg
Key exclusion criteria (5 listed)
- Age<18 years
- Dialysis duration of <4 or >4 hours
- Dialysis frequency of <3 or >3 times a week
- Dialysis on a central venous catheter
- A usual interdialytic weight gain <2 kg
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 |
|---|---|---|
| Hemocontrol hemodialysisEach participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. The Hemocontrol system guides the patients' blood volume along a predefined ideal relative blood volume trajectory, by continuously adjusting ultrafiltration volume and dialysate sodium concentration. | Device | HHD, SHD |
| Standard hemodialysisEach participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. During standard hemodialysis, a constant ultrafiltration rate and dialysate conductivity was used. | Device | HHD, SHD |
Primary outcome
Change in plasma vasopressin levels
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.
Plasma levels of the antidiuretic hormone, i.e. vasopressin
4 secondary outcomes
Change in systolic and diastolic blood pressure in mmHg
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in heart rate in beats per minute
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in relative blood volume in %
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in plasma sodium levels in mmol/L
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
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 12 May 2023.
- Derived from this study: PubMed 30134847Ettema EM, Kuipers J, van Faassen M, Groen H, van Roon AM, Lefrandt JD, Westerhuis R, Kema IP, van Goor H, Gansevoort RT, Gaillard CAJM, Franssen CFM. Effect of plasma sodium concentration on blood pressure regulators during hemodialysis: a randomized crossover study. BMC Nephrol. 2018 Aug 22;19(1):214. doi: 10.1186/s12882-018-0997-z.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard hemodialysis in people with Patients With End Stage Renal Disease on Hemodialysis, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Change in plasma vasopressin levels (time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.). 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 NCT03578510, which also lists 1 linked publication.
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 12 May 2023.