Why the study?
Online post-dilution HDF is associated with superior survival compared to standard HD, but the underlying mechanisms—potentially including reduced intradialytic hypotension and tissue injury—remain unclear.
Do different dialysis modalities, such as high-volume hemodiafiltration, reduce the incidence of intradialytic hypotension compared to standard hemodialysis in chronic dialysis patients?
Do different dialysis modalities, such as high-volume hemodiafiltration, reduce the incidence of intradialytic hypotension compared to standard hemodialysis in chronic dialysis patients?
The HOLLANT study is designed to evaluate whether different dialysis modalities, particularly high-volume hemodiafiltration, reduce intradialytic hypotension and associated tissue injury compared to standard hemodialysis.
HV-HDF reduces IDH episodes versus standard HD; supports hemodynamic stability as a mechanism underlying survival benefits in prior meta-analyses.
BACKGROUND: From a recent meta-analysis it appeared that online post-dilution hemodiafiltration (HDF), especially with a high convection volume (HV-HDF), is associated with superior overall and cardiovascular survival, if compared to standard hemodialysis (HD). The mechanism(s) behind this effect, however, is (are) still unclear. In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role. To address these items, the HOLLANT study was designed. METHODS: HOLLANT is a Dutch multicentre randomized controlled cross-over trial. In total, 40 prevalent dialysis patients will be included and, after a run-in phase, exposed to standard HD, HD with cooled dialysate, low-volume HDF and high-volume HDF (Dialog iQ® machine) in a randomized fashion. The primary endpoint is an intradialytic nadir in systolic blood pressure (SBP) of < 90 and < 100 mmHg for patients with predialysis SBP < 159 and ≥ 160 mmHg, respectively. The main secondary outcomes are 1) intradialytic left ventricle (LV) chamber quantification and deformation, 2) intradialytic hemodynamic profile of SBP, diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse pressure (PP), 3) organ and tissue damage, such as the release of specific cellular components, and 4) patient reported symptoms and thermal perceptions during each modality. DISCUSSION: The current trial is primarily designed to test the hypothesis that a lower incidence of intradialytic hypotension contributes to the superior survival of (HV)-HDF. A secondary objective of this investigation is the question whether changes in the intradialytic blood pressure profile correlate with organ dysfunction and tissue damage, and/or patient discomfort. TRIAL REGISTRATION: Registered Report Identifier: NCT03249532 # ( ClinicalTrials.gov ). Date of registration: 2017/08/15.
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Rootjes et al. (2021) studied this question.
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