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- Title
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).
- Authors
Rootjes, Paul A.; Nubé, Menso J.; de Roij van Zuijdewijn, Camiel L. M.; Wijngaarden, Gertrude; Grooteman, Muriel P. C.
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Registered Report Identifier: NCT03249532 # ( ClinicalTrials.gov ). Date of registration: 2017/08/15.
- Subjects
HEMODIALYSIS patients; SOFT tissue injuries; SYSTOLIC blood pressure; HEMODYNAMICS; BLOOD pressure; TREATMENT of chronic kidney failure; CHRONIC kidney failure complications; CHRONIC kidney failure; ECHOCARDIOGRAPHY; RESEARCH; OXYGEN; DNA; BODY temperature; HEMODIAFILTRATION; RESEARCH methodology; EVALUATION research; PATIENT monitoring; COMPARATIVE studies; DRUGS; HEMODIALYSIS; BLOOD volume; CROSSOVER trials; COLD (Temperature)
- Publication
BMC Nephrology, 2021, Vol 22, Issue 1, p1
- ISSN
1471-2369
- Publication type
journal article
- DOI
10.1186/s12882-021-02331-z