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Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial.
Mekontso Dessap, Armand; Bagate, François; Delmas, Clément; Morichau-Beauchant, Tristan; Cholley, Bernard; Cariou, Alain; Lattuca, Benoit; Moussa, Mouhamed; Mongardon, Nicolas; Fard, Damien; Schmidt, Matthieu; Bouglé, Adrien; Kerneis, Mathieu; Vivier, Emmanuel; Roubille, François; Duprey, Matthieu; Decalf, Véronique; Genet, Thibaud; Merzoug, Messaouda; Audureau, Etienne; Squara, Pierre.
Afiliação
  • Mekontso Dessap A; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation, F-94010, Créteil, France. armand.dessap@aphp.fr.
  • Bagate F; Univ Paris Est Créteil, CARMAS, F-94010, Créteil, France. armand.dessap@aphp.fr.
  • Delmas C; Univ Paris Est Créteil, INSERM, IMRB, F-94010, Créteil, France. armand.dessap@aphp.fr.
  • Morichau-Beauchant T; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation, F-94010, Créteil, France.
  • Cholley B; Univ Paris Est Créteil, CARMAS, F-94010, Créteil, France.
  • Cariou A; Univ Paris Est Créteil, INSERM, IMRB, F-94010, Créteil, France.
  • Lattuca B; Intensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France.
  • Moussa M; Centre Cardiologique du Nord, service de réanimation, St Denis, France.
  • Mongardon N; AP-HP, Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation, Paris, France.
  • Fard D; AP-HP, Centre-Université de Paris, Hôpital Cochin, Service de Médecine Intensive Réanimation, Paris, France.
  • Schmidt M; Hôpital Universitaire de Nîmes, Unité de soins Intensifs cardiologique, Nîmes, France.
  • Bouglé A; CHU de Lille, Service d'Anesthésie-Réanimation cardiovasculaire, Lille, France.
  • Kerneis M; U955-IMRB, Equipe 03 "Pharmacologie et Technologies pour les Maladies Cardiovasculaires (PROTECT)", Inserm, Univ Paris Est Créteil (UPEC), Ecole Nationale Vétérinaire d'Alfort (EnVA), F-94700, Maisons-Alfort, France.
  • Vivier E; AP-HP, Hôpitaux Universitaires Henri Mondor, Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, F-94010, Créteil, France.
  • Roubille F; AP-HP, Hôpitaux Universitaires Henri-Mondor, Unité de soins Intensifs cardiologique, F-94010, Créteil, France.
  • Duprey M; AP-HP, Hôpital Pitié-Salpétrière, Service de Médecine Intensive Réanimation, Paris, France.
  • Decalf V; AP-HP, Hôpital Pitié-Salpétrière, Service d'Anesthésie-Réanimation cardiovasculaire, Paris, France.
  • Genet T; AP-HP, Hôpital Pitié-Salpétrière, Unité de soins Intensifs cardiologique, Paris, France.
  • Merzoug M; Centre Hospitalier Saint Joseph Saint Luc, Service de Médecine Intensive Réanimation, Lyon, France.
  • Audureau E; PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, INI-CRT, Montpellier, France.
  • Squara P; Grand Hôpital de l'Est Francilien, Hôpital Jossigny, Service de Médecine Intensive Réanimation, Marne la Vallée, France.
Trials ; 23(1): 4, 2022 Jan 03.
Article em En | MEDLINE | ID: mdl-34980224
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.
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Choque Cardiogênico / COVID-19 Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline Limite: Adult / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Choque Cardiogênico / COVID-19 Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline Limite: Adult / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article