Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis
HOLLANT
Effect of High-volume Online hemodiafiLtration on Intra-diaLytic hemodynAmic (iN)sTability and Cardiac Function in Chronic Hemodialysis Patients (the HOLLANT Study)
1 other identifier
interventional
40
1 country
3
Brief 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 function will be investigated in a prospective cross over trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedNovember 30, 2021
November 1, 2021
2.7 years
May 23, 2017
November 28, 2021
Conditions
Outcome Measures
Primary Outcomes (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)
up to 4 hours (= one dialysis treatment); assessed during 3 treatments on each modality
Secondary Outcomes (1)
diastolic dysfunction during treatment
up to 4 hours (= one dialysis treatment); assessed during 1 treatment on each modality
Other Outcomes (21)
systolic blood pressure
up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality
diastolic blood pressure
up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality
mean arterial blood pressure
up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality
- +18 more other outcomes
Study Arms (4)
standard hemodialysis
ACTIVE COMPARATORprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 0 Liters (L)
cool hemodialysis
ACTIVE COMPARATORprescription of dialysate temperature: 35.5 degrees celsius prescription of convection volume: 0 L
low volume hemodiafiltration
ACTIVE COMPARATORprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L
high volume hemodiafiltration
ACTIVE COMPARATORprescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L
Interventions
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Niercentrum aan de Amstel, Amstelveen, Netherlandscollaborator
- B.Braun Avitum AGcollaborator
Study Sites (3)
St Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM, Netherlands
Niercentrum aan de Amstel
Amstelveen, 1186 AM, Netherlands
VUmc
Amsterdam, Netherlands
Related Publications (1)
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.
PMID: 33858390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muriel PC Grooteman, MD PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- treatment period will not be available to the assessors of secondary outcomes.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
May 23, 2017
First Posted
August 15, 2017
Study Start
June 1, 2018
Primary Completion
February 15, 2021
Study Completion
February 15, 2021
Last Updated
November 30, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share