TY - JOUR
T1 - Inotrope versus placebo therapy in cardiogenic shock
T2 - Rationale and study design of the CAPITAL DOREMI2 trial
AU - Parlow, Simon
AU - Santo, Pietro Di
AU - Sterling, Lee H.
AU - Goodliffe, Laura
AU - Motazedian, Pouya
AU - Prosperi-Porta, Graeme
AU - Morgan, Baylie
AU - Koopman, Zandra
AU - Jung, Richard G.
AU - Lepage-Ratte, Melissa Fay
AU - Robinson, Lisa
AU - Feagan, Hannah
AU - Simard, Trevor
AU - Wells, George A.
AU - Kyeremanteng, Kwadwo
AU - Ainsworth, Craig
AU - Amin, Faizan
AU - Marbach, Jeffrey A.
AU - Fernando, Shannon M.
AU - Labinaz, Marino
AU - Belley-Cote, Emilie P.
AU - Hibbert, Benjamin
AU - Mathew, Rebecca
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/8
Y1 - 2023/8
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ahj.2023.04.010
DO - 10.1016/j.ahj.2023.04.010
M3 - Article
C2 - 37094667
AN - SCOPUS:85159228889
SN - 0002-8703
VL - 262
SP - 83
EP - 89
JO - American heart journal
JF - American heart journal
ER -