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Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: — EVERDAC  

Acute Circulatory Failure Clinical Trial

Official title:
Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)

Clinical Trial Summary

The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses: 1. a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%). 2. a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality. Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03680963
Study type Interventional
Source University Hospital, Tours
Contact
Status Completed
Phase N/A
Start date November 15, 2018
Completion date February 28, 2023
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