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)

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.

Physical intradialytic patient‐reported outcome measures in haemodialysis and haemodiafiltration: A cross‐over study

“…Yet, to minimize patients' discomfort the underlying protocol was designed in its current form. 17 Second, although the genuine DSI ensures content validity and test and retest reliability, our adaptations may need further confirmation. The validity of the question about the length of the recovery time was already shown before.…”

“…The duration of each treatment modality was 2 weeks, which may have been too short to affect both the generation and/or the disappearance of dialysis induced symptoms. Yet, to minimize patients' discomfort the underlying protocol was designed in its current form 17 . Second, although the genuine DSI ensures content validity and test and retest reliability, our adaptations may need further confirmation.…”

“…The current investigation is part of an open‐label, multicenter, RCT in prevalent dialysis patients. Below, we present a summary of the methods which have been described in detail elsewhere 17 . Forty‐five chronic dialysis patients of an independent clinic (Niercentrum aan de Amstel, Amstelveen, The Netherlands), a large community hospital (St. Antonius hospital, Nieuwegein, The Netherlands) and an university hospital (Amsterdam UMC, location VU University medical center, Amsterdam, The Netherlands) were recruited.…”

“…The electrolyte composition of the dialysis fluid was: Na 138–140 mmol/L; K 2.0–3.0 mmol/L; HCO3 30–35 mmol/L; Ca 1.25–1.75 mmol/L; Mg 0.5 mmol/L; Cl 108–109.5 mmol/L; glucose 5.6 mmol/L; acetate 3 mmol/L. In addition, for each patient, the dialysis prescription was fixed during the entire conduct of the study (apart from the treatment settings depending on the study modality), as described elsewhere 17 . All patients received their usual dose of low molecular weight heparin anticoagulation (i.e., nadroparin or dalteparin).…”

High-Volume Hemodiafiltration and Cool Hemodialysis Have a Beneficial Effect on Intradialytic Hemodynamics: A Randomized Cross-Over Trial of Four Intermittent Dialysis Strategies

“…This study (ClinicalTrials.gov identifier NCT03249532) is an open, cross-over, multi-center intervention RCT in patients treated with intermittent extracorporeal renal replacement therapy (ERRT), as described in detail elsewhere. 30 In short, patients were subjected to four ERRTs in a random order: 1) S-HD (Td 36.5°C), 2) C-HD (Td 35.5°C), 3) HDF (Td 36.5°C) with a target convection volume of 15 l/session (LV-HDF) and 4) HDF (Td 36.5°C) with a target convection volume ≥23 l/session (HV-HDF). Total study duration was 10 weeks, divided into a two-week run-in period and an eight-week experimental phase (two weeks per modality).…”