Dataset Information

Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol.

ABSTRACT:

Introduction

The use of peripheral indwelling arterial catheter for haemodynamic monitoring is widespread in the intensive care unit and is recommended in patients with shock. However, there is no evidence that the arterial catheter could improve patient's outcome, whereas the burden of morbidity generated is significant (pain, thrombosis, infections). We hypothesise that patients with shock may be managed without an arterial catheter.

Methods and analysis

The EVERDAC study is an investigator-initiated, pragmatic, multicentre, randomised, controlled, open-label, non-inferiority clinical trial, comparing a less invasive intervention (ie, no arterial catheter insertion until felt absolutely needed, according to predefined safety criteria) or usual care (ie, systematic arterial catheter insertion in the early hours of shock). 1010 patients will be randomised with a 1:1 ratio in two groups according to the strategy. The primary outcome is all-cause mortality by 28 days after inclusion. A health economic analysis will be carried out.

Ethics and dissemination

The study has been approved by the Ethics Committee (Comité de Protection des Personnes Île de France V, registration number 61606 CAT 2, 19 july 2018) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03680963.

SUBMITTER: Muller G

PROVIDER: S-EPMC8442046 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Early ve<b>r</b>sus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol.

Muller Grégoire G Kamel Toufik T Contou Damien D Ehrmann Stephan S Martin Maëlle M Quenot Jean-Pierre JP Lacherade Jean-Claude JC Boissier Florence F Monnier Alexandra A Vimeux Sylvie S Brunet Houdard Solène S Tavernier Elsa E Boulain Thierry T

BMJ open 20210914 9

<h4>Introduction</h4>The use of peripheral indwelling arterial catheter for haemodynamic monitoring is widespread in the intensive care unit and is recommended in patients with shock. However, there is no evidence that the arterial catheter could improve patient's outcome, whereas the burden of morbidity generated is significant (pain, thrombosis, infections). We hypothesise that patients with shock may be managed without an arterial catheter.<h4>Methods and analysis</h4>The EVERDAC study is an ...[more]

PMID: 34521655

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