Effect of intraoperative dexamethasone on major complications and mortality among infants undergoing cardiac surgery The DECISION Randomized Clinical Trial
JAMA
; 323(24): 2485-2492, June., 2020. tab., graf.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1123020
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
IMPORTANCE Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain. OBJECTIVE To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018. INTERVENTIONS The dexamethasone group (n = 194) received 1mg/kg of dexamethasone; the control group (n = 200) received an equivolume of 0.9%sodium chloride intravenously after anesthesia induction. MAIN OUTCOMES AND MEASURES The primary end pointwas a composite of death, nonfatalmyocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization. RESULTS All of the 394 patients randomized (median age, 6 months; 47.2%boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95%CI, −0.8%to 15.3%; hazard ratio, 0.82; 95%CI, 0.60 to 1.10; P = .20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group. CONCLUSIONS AND RELEVANCE Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.
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Coleções:
Bases de dados nacionais
/
Brasil
Contexto em Saúde:
ODS3 - Saúde e Bem-Estar
/
ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
/
ODS3 - Meta 3.2 Reduzir as mortes de recém nascidos e crianças com menos de 5 anos
Problema de saúde:
Meta 3.2: Reduzir as mortes de recém nascidos e crianças com menos de 5 anos
/
Saúde Mental e Transtornos do Comportamento
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Doenças Não Transmissíveis
Base de dados:
Sec. Est. Saúde SP
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SESSP-IDPCPROD
Assunto principal:
Ponte Cardiopulmonar
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Complicações Cognitivas Pós-Operatórias
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Procedimentos Cirúrgicos Cardíacos
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Cuidados Intraoperatórios
Tipo de estudo:
Ensaio clínico controlado
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Estudo prognóstico
Limite:
Criança
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Feminino
/
Humanos
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Masculino
/
Recém-Nascido
Idioma:
Inglês
Revista:
JAMA
Ano de publicação:
2020
Tipo de documento:
Artigo
Instituição/País de afiliação:
Dante Pazzanese Institute of Cardiology/BR
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Federal Centre of Cardiovascular Surgery/RU
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IRCCS San Raffaele Scientific Institute/IT
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Meshalkin National Medical Research Center/RU
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National Medical Research Center/RU
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Shanghai Children's Medical Center/CN