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)

Paul A Rootjes, Menso J Nubé, Camiel L M de Roij van Zuijdewijn, Gertrude Wijngaarden, Muriel P C Grooteman, Paul A Rootjes, Menso J Nubé, Camiel L M de Roij van Zuijdewijn, Gertrude Wijngaarden, Muriel P C Grooteman

Abstract

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.

Keywords: Hemodiafiltration; Hemodialysis; Intradialytic blood pressure; Intradialytic patient tolerance; Intradialytic tissue injury; Multicentre randomized controlled cross-over trial.

Conflict of interest statement

PAR, MJN and MPCG report grant support from Niercentrum aan de Amstel, Elyse Klinieken, and B. Braun Avitum AG. All the other authors declared no competing interests.

Figures

Fig. 1
Fig. 1
Overview of study scheme. The run-in phase during week − 1 and week 0 (total duration of 2 weeks) is followed by the four different dialysis treatment modalities (S-HD, C-HD, LV-HDF, HV-HDF) in a randomized order (total duration of 8 weeks).  = Non-invasive advanced hemodynamic monitoring (Clearsight) during the first or second treatment of the last week and measurement of blood pressure every 15 min;  = assessment of STE, blood sampling and measurement of blood pressure every 15 min;  = measurement of blood pressure every 30 min
Fig. 2
Fig. 2
Visual Analogue Scale – Thermal Perception (VAS-TP). Thermal perception will be assessed by the Visual Analogue Scale - Thermal Perception (VAS-TP) before HD(F) and after 1 and 3 h. Upon the continuous line patients can indicate their actual thermal perception

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