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).

Autor: Rootjes PA; Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands., Nubé MJ; Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands., de Roij van Zuijdewijn CLM; Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands., Wijngaarden G; Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands., Grooteman MPC; Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands. mpc.grooteman@amsterdamumc.nl.
Jazyk: angličtina
Zdroj: BMC nephrology [BMC Nephrol] 2021 Apr 15; Vol. 22 (1), pp. 131. Date of Electronic Publication: 2021 Apr 15.
DOI: 10.1186/s12882-021-02331-z
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz: