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End Stage Renal Disease (ESRD)HOLLANTNCT03249532

Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis

A study testing standard hemodialysis, cool hemodialysis and low volume hemodiafiltration in people with End Stage Renal Disease (ESRD) and Hemodialysis, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques (differing in dialysate temperature and the absence/presence of convective clearance) on intradialytic hemodynamic stability and cardiac… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
standard hemodialysis, cool hemodialysis and low volume hemodiafiltration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesNetherlands
Study dates
1 Jun 2018to 15 Feb 2021
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

  • treatment with HD or HDF 3 x per week during at least 4 hours for at least 2 months
  • ability to understand study procedures
  • willingness to provide informed consent
  • single pool Kt/V urea (spKt/Vurea) ≥ 1.2
  • achievement of blood flow of ≥360 ml/min and/or convection volume of >23 Liter per treatment during the run-in phase

Who cannot join

  • - current age < 18 years
  • severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
  • life expectancy < 3 months
  • participation in another clinical intervention trial

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites
  • Niercentrum aan de Amstel

    Amstelveen, 1186 AM

  • VUmc

    Amsterdam

  • St Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3435 CM

Other trials in Netherlands

About this study

Official title: Effect of High-volume Online hemodiafiLtration on Intra-diaLytic hemodynAmic (iN)sTability and Cardiac Function in Chronic Hemodialysis Patients (the HOLLANT Study)

Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques (differing in dialysate temperature and the absence/presence of convective clearance) on intradialytic hemodynamic stability and cardiac function will be investigated in a prospective cross over trial.

Read the detailed description

Despite the use of high permeable dialyzers, which combine diffusive with convective clearance, the clinical outcome of hemodialysis (HD) patients remains poor. In post-dilution online hemodiafiltration (denoted further on as HDF) diffusive clearance is similar to HD, while the amount of convective transport is considerable increased. Recently, 4 randomized controlled trails have been published which compared HD with HDF. Although the results of the individual studies were inconclusive, a recent meta-analysis, using individual patient data of these studies, showed a superior outcome for patients treated with HDF. The largest mortality reduction was obtained in patients receiving the highest convection volume (high-volume HDF [HV-HDF] >23 L/1.73 m2/session): all-cause mortality [22% (95 % confidence interval [CI] 2-38)], cardiovascular disease (CVD) mortality [31% (95 % CI 0-53)].

It is far from clear, however, why (HV)HDF is associated with an improved survival. Both long term and short term effects may be involved. With respect to the latter, the intra-dialytic removal of middle molecular weight (MMW) uremic retention products and a superior bio-incompatibility (BI) profile may play a role. In addition, treatment with HDF may induce less intra-dialytic hypotension (IDH) and less tissue injury. Enhanced removal of the MMW substance FGF23 may reduce the intra-dialytic acute phase reaction (APR), which is regarded a chief element of HD-induced BI. Other key components which may contribute to IDH and are supposed to be alleviated by HDF, include dialysis-induced hypoxia and intra-dialytic extracellular vesicle release. Patho-physiologically, IDH depends both on a decline in the circulating blood volume and an impaired response to hypovolaemia. As a result, venous return, cardiac output and peripheral vascular resistance are impaired. Since IDH is reduced by HD with cool dialysate (C-HD), thermal factors may play an important role.

Microcirculatory dysfunction is a prominent feature of HD patients. Since IDH occurs in 20-30% of the sessions, any interference with an already abnormal perfusion may further deteriorate the structure and function of vital organs, such as the brain, gut and heart. HD-associated cardiomyopathy, which is considered a model of repetitive organ ischemia-reperfusion injury, is superimposed on the cardiac changes resulting from the various inflammatory and metabolic derangements of pre-dialysis kidney disease. As measured by imaging techniques and biomarkers, HD induces a fall in cardiac perfusion and elicits tissue injury. While cardiac MRI is considered the reference method for LV quantification, intra-dialytic measurements can only be obtained in stable patients who can be safely transferred to the radiology department. Echocardiography, though, can be performed in all individuals at the bed-side, including hypotension-prone patients. Because of its superiority over standard echocardiography, especially with respect to diastolic (dys)function, speckle tracking echocardiography will be used in the present study.

As mentioned, the effect on long term survival is especially prominent when HV-HDF is applied. Theoretically, HV-HDF is also the preferred treatment to circumvent dialysis-induced IDH, and hence, to alleviate the repetitive intra-dialytic tissue damage. Therefore, the following hypotheses will be tested:

  1. intra-dialytic hemodynamic stability is better preserved during HV-HDF as compared to standard (S)-HD, C-HD and low volume (LV)-HDF;
  2. mainly as a result of a better intra-dialytic hemodynamic stability, the severity of organ injury, especially the heart, is least evident during HV-HDF;
  3. the mechanism of a better preserved intra-dialytic hemodynamic stability during HV-HDF depends on its superior thermal balance and/or bio-incompatibility, clearance of MMW substances, or a combination of these items.

Worldwide, however, (HV)HDF is only limited available. Since intradialytic hemodynamic instability may contribute substantially to the poor clinical prospects of end-stage-kidney-disease (ESKD) patients, these individuals may benefit from each maneuver that minimizes the number and severity of intradialytic hypotensive episodes. Therefore, the question which of the comparator treatments [(S)-HD, C-HD and LV-HDF] has the best intradialytic hemodynamic stability, appears relevant as well.

Being tested
standard hemodialysis, cool hemodialysis, low volume hemodiafiltration, high volume hemodiafiltration
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.

  • standard hemodialysisDevice

    hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable

  • cool hemodialysisDevice

    hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable

  • low volume hemodiafiltrationDevice

    hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L

  • high volume hemodiafiltrationDevice

    hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L

Study groups in NCT03249532
Study groupRoleWhat they receive
standard hemodialysisActive comparatorprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 0 Liters (L)
Receives: Device: cool hemodialysis; Device: low volume hemodiafiltration; Device: high volume hemodiafiltration
cool hemodialysisActive comparatorprescription of dialysate temperature: 35.5 degrees celsius prescription of convection volume: 0 L
Receives: Device: standard hemodialysis; Device: low volume hemodiafiltration; Device: high volume hemodiafiltration
low volume hemodiafiltrationActive comparatorprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L
Receives: Device: standard hemodialysis; Device: cool hemodialysis; Device: high volume hemodiafiltration
high volume hemodiafiltrationActive comparatorprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L
Receives: Device: standard hemodialysis; Device: cool hemodialysis; Device: low volume hemodiafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intradialytic hypotension

    nadir in systolic blood pressure (SBP) of 90 mmHg for patient with predialysis SBP <160mmHg and a nadir of 100 mmHg for patients with predialysis SBP ≥160 mmHg during treatment (blood pressure will be measured before and every 15 minutes after the start of dialysis during the treatment)

    Measured: up to 4 hours (= one dialysis treatment); assessed during 3 treatments on each modality

Secondary outcomes (1)
  1. diastolic dysfunction during treatment

    speckle tracking echocardiography will be performed before, after 60 minutes of dialysis and after and after 3,5 hours

    Measured: up to 4 hours (= one dialysis treatment); assessed during 1 treatment on each modality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start1 Jun 2018
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

Resources

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
Model description
prospective, cross over, randomized order
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249532
Sponsor's protocol ID
ABR 61210
Acronym
HOLLANT
Status last verified
Nov 2021
First submitted
23 May 2017
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rootjes PA, Nube MJ, de Roij van Zuijdewijn CLM, Wijngaarden G, Grooteman MPC. Effect of various dialysis modalities on intradialytic hemodynamics, tissue injury and patient discomfort in chronic dialysis patients: design of a randomized cross-over study (HOLLANT). BMC Nephrol. 2021 Apr 15;22(1):131. doi: 10.1186/s12882-021-02331-z.

    PubMed 33858390

Questions about this trial

What is this clinical trial studying?

A study testing standard hemodialysis, cool hemodialysis and low volume hemodiafiltration in people with End Stage Renal Disease (ESRD) and Hemodialysis, run by Amsterdam UMC, location VUmc at 3 sites 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 5 inclusion and 4 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

intradialytic hypotension (time frame: up to 4 hours (= one dialysis treatment); assessed during 3 treatments on each modality). 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 NCT03249532, 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 30 Nov 2021.

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