EvaLuation of early CRRT and beta-blocker InTervention in patients with ECMO (ELITE) trial: study protocol for a 2 × 2 partial factorial randomized controlled trial

Autor: Xiaofang Wang, Hong Wang, Xin Du, Zhiyan Wang, Chenglong Li, Craig S. Anderson, Jinying Zhang, Xiaotong Hou, Jianzeng Dong
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Trials, Vol 23, Iss 1, Pp 1-9 (2022)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-022-06617-x
Popis: Abstract Background In critically ill patients requiring extracorporeal membrane oxygenation (ECMO) therapy, early initiation of continuous renal replacement therapy (CRRT) and beta-blockade of catecholamine-induced inotropic effects may improve outcomes. Methods A 2 × 2 partial factorial randomized controlled trial in eligible ECMO patients without a clear indication or contraindication to either intervention is centrally randomly assigned to (A) early or conventional-indicated CRRT and/or (B) beta-blocker or usual care. The primary outcome is all-cause mortality at 30 days for both arms. A total of 496 participants provides 80% power to determine a 20% risk reduction in mortality at 30 days with 5% type I error. Discussion This trial will help define the role of early CRRT and beta-blockade in ECMO patients. There have been 89 patients enrolled at 10 hospitals in study A and is ongoing. However, study B was stopped in August 2019 in the absence of any patients being enrolled. Trial registration ClinicalTrials.gov NCT03549923 . Registered on 8 June 2018. World Health Organization International Clinical Trials Registry Platform (WHO ICTEP) network. The Ethics Committee of Beijing Anzhen Hospital Approval ID is 2018013.
Databáze: Directory of Open Access Journals
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