Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial
Armand Mekontso Dessap,
François Bagate,
Clément Delmas,
Tristan Morichau-Beauchant,
Bernard Cholley,
Alain Cariou,
Benoit Lattuca,
Mouhamed Moussa,
Nicolas Mongardon,
Damien Fard,
Matthieu Schmidt,
Adrien Bouglé,
Mathieu Kerneis,
Emmanuel Vivier,
François Roubille,
Matthieu Duprey,
Véronique Decalf,
Thibaud Genet,
Messaouda Merzoug,
Etienne Audureau,
Pierre Squara
Affiliations
Armand Mekontso Dessap
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation
François Bagate
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation
Clément Delmas
Intensive Cardiac Care Unit, Rangueil University Hospital
Tristan Morichau-Beauchant
Centre Cardiologique du Nord, service de réanimation
Bernard Cholley
AP-HP, Hôpital Européen Georges Pompidou, Service d’Anesthésie-Réanimation
Alain Cariou
AP-HP, Centre-Université de Paris, Hôpital Cochin, Service de Médecine Intensive Réanimation
Benoit Lattuca
Hôpital Universitaire de Nîmes, Unité de soins Intensifs cardiologique
Mouhamed Moussa
CHU de Lille, Service d’Anesthésie-Réanimation cardiovasculaire
Nicolas Mongardon
U955-IMRB, Equipe 03 “Pharmacologie et Technologies pour les Maladies Cardiovasculaires (PROTECT)”, Inserm, Univ Paris Est Créteil (UPEC), Ecole Nationale Vétérinaire d’Alfort (EnVA)
Damien Fard
AP-HP, Hôpitaux Universitaires Henri-Mondor, Unité de soins Intensifs cardiologique
Matthieu Schmidt
AP-HP, Hôpital Pitié-Salpétrière, Service de Médecine Intensive Réanimation
Adrien Bouglé
AP-HP, Hôpital Pitié-Salpétrière, Service d’Anesthésie-Réanimation cardiovasculaire
Mathieu Kerneis
AP-HP, Hôpital Pitié-Salpétrière, Unité de soins Intensifs cardiologique
Emmanuel Vivier
Centre Hospitalier Saint Joseph Saint Luc, Service de Médecine Intensive Réanimation
François Roubille
PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, INI-CRT
Matthieu Duprey
Grand Hôpital de l’Est Francilien, Hôpital Jossigny, Service de Médecine Intensive Réanimation
Véronique Decalf
Centre Hospitalier de Pontoise, Unité de soins Intensifs cardiologique
Thibaud Genet
CHU de Tours, Unité de soins Intensifs cardiologique
Messaouda Merzoug
CMC Ambroise Paré, département de recherche clinique
Etienne Audureau
AP-HP, Hôpitaux Universitaires Henri-Mondor, Service de recherche clinique
Pierre Squara
CMC Ambroise Paré, département de recherche clinique
Abstract Background Cardiogenic shock (CS) is a life-threatening condition characterized by circulatory insufficiency caused by an acute dysfunction of the heart pump. The pathophysiological approach to CS has recently been enriched by the tissue consequences of low flow, including inflammation, endothelial dysfunction, and alteration of the hypothalamic-pituitary-adrenal axis. The aim of the present trial is to evaluate the impact of early low-dose corticosteroid therapy on shock reversal in adults with CS. Method/design This is a multicentered randomized, double-blind, placebo-controlled trial with two parallel arms in adult patients with CS recruited from medical, cardiac, and polyvalent intensive care units (ICU) in France. Patients will be randomly allocated into the treatment or control group (1:1 ratio), and we will recruit 380 patients (190 per group). For the treatment group, hydrocortisone (50 mg intravenous bolus every 6 h) and fludrocortisone (50 μg once a day enterally) will be administered for 7 days or until discharge from the ICU. The primary endpoint is catecholamine-free days at day 7. Secondary endpoints include morbidity and all-cause mortality at 28 and 90 days post-randomization. Pre-defined subgroups analyses are planned, including: postcardiotomy, myocardial infarction, etomidate use, vasopressor use, and adrenal profiles according the short corticotropin stimulation test. Each patient will be followed for 90 days. All analyses will be conducted on an intention-to-treat basis. Discussion This trial will provide valuable evidence about the effectiveness of low dose of corticosteroid therapy for CS. If effective, this therapy might improve outcome and become a therapeutic adjunct for patients with CS. Trial registration ClinicalTrials.gov , NCT03773822 . Registered on 12 December 2018
