NCT03680963

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,010 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Circulatory Failure

Interventions

Type	Name	Description
PROCEDURE	Non-invasive strategy	No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached. In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure).
PROCEDURE	Control strategy	An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.

Timeline

• Start date: 2018-11-15
• Primary completion: 2022-11-29
• Completion: 2023-02-28
• First posted: 2018-09-21
• Last updated: 2025-12-22

Locations

9 sites across 1 country: France