Skip to Main content Skip to Navigation
Journal articles

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.
Document type :
Journal articles
Complete list of metadata

https://www.hal.inserm.fr/inserm-03470917
Contributor : Odile Malbec Connect in order to contact the contributor
Submitted on : Wednesday, December 8, 2021 - 3:41:46 PM
Last modification on : Friday, August 5, 2022 - 11:39:59 AM
Long-term archiving on: : Wednesday, March 9, 2022 - 6:56:04 PM

File

e044719.full.pdf
Publication funded by an institution

Identifiers

Citation

Grégoire Muller, Toufik Kamel, Damien Contou, Stephan Ehrmann, Maëlle Martin, et al.. 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. BMJ Open, BMJ Publishing Group, 2021, 11 (9), pp.e044719. ⟨10.1136/bmjopen-2020-044719⟩. ⟨inserm-03470917⟩

Share

Metrics

Record views

38

Files downloads

26