Inotrope versus placebo therapy in cardiogenic shock: Rationale and study design of the CAPITAL DOREMI2 trial.

Autor:	Parlow S; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Santo PD; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Division of Critical Care Medicine, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada., Sterling LH; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Goodliffe L; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Motazedian P; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Prosperi-Porta G; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Morgan B; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Koopman Z; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Jung RG; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada., Lepage-Ratte MF; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada., Robinson L; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Feagan H; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Simard T; Department of Cardiovascular Diseases, Mayo Clinic School of Medicine, Rochester, Minnesota., Wells GA; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Cardiovascular Research Methods Center, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Kyeremanteng K; Division of Critical Care Medicine, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada., Ainsworth C; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Amin F; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Marbach JA; Division of Cardiology, Knight Cardiovascular Institute, Oregon Health & Sciences University, Portland, Oregon, USA., Fernando SM; Department of Critical Care, Lakeridge Health Corporation, Oshawa, Ontario, Canada., Labinaz M; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Belley-Cote EP; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada., Hibbert B; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada., Mathew R; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: rmathew@ottawaheart.ca.
Jazyk:	angličtina
Zdroj:	American heart journal [Am Heart J] 2023 Aug; Vol. 262, pp. 83-89. Date of Electronic Publication: 2023 Apr 23.
DOI:	10.1016/j.ahj.2023.04.010
Abstrakt:	Background: Cardiogenic shock (CS) is a state of end-organ hypoperfusion related to cardiac dysfunction. Current guidelines recommend consideration of inotrope therapy in patients with CS, however no robust data support their use. The purpose of the CAPITAL DOREMI2 trial is to examine the efficacy and safety of inotrope therapy against placebo in the initial resuscitation of patients with CS. Methods and Design: This is a multi-center, double-blind, randomized, placebo-controlled trial comparing single-agent inotrope therapy to placebo in patients with CS. A total of 346 participants with Society for Cardiovascular Angiography and Interventions class C or D CS will be randomized in a 1:1 fashion to inotrope or placebo therapy, which will be administered over a 12-hour period. After this period, participants will continue open-label therapies at the discretion of the treating team. The primary outcome is a composite of all-cause in-hospital death, and, as measured during the 12-hour intervention period, any of: sustained hypotension or high dose vasopressor requirements, lactate greater than 3.5 mmol/L at 6 hours or thereafter, need for mechanical circulatory support, arrhythmia leading to emergent electrical cardioversion, and resuscitated cardiac arrest. All participants will be followed for the duration of their hospitalization, and secondary outcomes will be assessed at the time of discharge. Implication: This trial will be the first to establish the safety and efficacy of inotrope therapy against placebo in a population of patients with CS and has the potential to alter the standard care provided to this group of patients. Competing Interests: Conflict of interest None. (Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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