1. 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
- Author
-
Toufik Kamel, Damien Contou, Jean-Pierre Quenot, Alexandra Monnier, Thierry Boulain, Jean-Claude Lacherade, Maelle Martin, Sylvie Vimeux, Elsa Tavernier, Grégoire Muller, Solène Brunet Houdard, Florence Boissier, Stephan Ehrmann, Centre Hospitalier Régional d'Orléans (CHRO), Réseau CRICS-TRIGGERSEP [CHRU Tours] (F-CRIN research network), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre hospitalier Argenteuil (CH Argenteuil), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [Tours], Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Centre hospitalier de Montauban (CH Montauban), MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), and Malbec, Odile
- Subjects
medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Informed consent ,law ,Medicine ,health economics ,030212 general & internal medicine ,adult intensive & critical care ,Protocol (science) ,clinical trials ,business.industry ,030208 emergency & critical care medicine ,General Medicine ,Arterial catheter ,medicine.disease ,Intensive care unit ,Thrombosis ,3. Good health ,Clinical trial ,[SDV] Life Sciences [q-bio] ,Shock (circulatory) ,Emergency medicine ,medicine.symptom ,business - Abstract
IntroductionThe 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 analysisThe 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 disseminationThe 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 numberNCT03680963.
- Published
- 2021