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

Trials. 2022 Aug 19;23(1):684. doi: 10.1186/s13063-022-06617-x.

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.

Keywords: Acute kidney injury; Cardiogenic shock; Extracorporeal membrane oxygenation; Mortality; Randomization; Renal replacement therapy.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Continuous Renal Replacement Therapy*
  • Critical Illness / therapy
  • Extracorporeal Membrane Oxygenation* / methods
  • Humans
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT03549923