TY - JOUR
T1 - 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)
T2 - design of a randomized cross-over study (HOLLANT)
AU - Rootjes, Paul A.
AU - Nubé, Menso J.
AU - de Roij van Zuijdewijn, Camiel L. M.
AU - Wijngaarden, Gertrude
AU - Grooteman, Muriel P. C.
N1 - Funding Information: This study is supported by unrestricted grants from Niercentrum aan de Amstel, Amstelveen, The Netherlands; and B. Braun Avitum AG, Melsungen, Germany. There will be no involvement in the collection, analysis and interpretation of data, or in the reporting of the results. Funding Information: 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. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Hemodiafiltration
KW - Hemodialysis
KW - Intradialytic blood pressure
KW - Intradialytic patient tolerance
KW - Intradialytic tissue injury
KW - Multicentre randomized controlled cross-over trial
KW - Biomarkers/blood
KW - Blood Pressure
KW - Blood Volume
KW - Body Temperature
KW - Cold Temperature
KW - Cross-Over Studies
KW - DNA, Bacterial/blood
KW - Dialysis Solutions
KW - Echocardiography
KW - Extracellular Vesicles/metabolism
KW - Hemodiafiltration/adverse effects
KW - Hemodynamics
KW - Humans
KW - Kidney Failure, Chronic/complications
KW - Monitoring, Physiologic/methods
KW - Oxygen/blood
UR - http://www.scopus.com/inward/record.url?scp=85104398411&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12882-021-02331-z
DO - https://doi.org/10.1186/s12882-021-02331-z
M3 - Article
C2 - 33858390
SN - 1471-2369
VL - 22
SP - 131
JO - BMC nephrology
JF - BMC nephrology
IS - 1
M1 - 131
ER -