drugset / Trial / NCT04663555

Summary

REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed.

Timeline

Start
2021-02-02
Primary completion
2022-03-09
Completion
2023-02-23

Outcome

Missed primary endpoint

paper with an absolute difference of + 0.81 days (95% CI - 2.12-3.73 days). PMID 39710693 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 6 mg —
Subject Dexamethasone Small molecule 10 mg —