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Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery : The DECISION Randomized Clinical Trial. / Lomivorotov, Vladimir; Kornilov, Igor; Boboshko, Vladimir et al.

In: JAMA - Journal of the American Medical Association, Vol. 323, No. 24, 23.06.2020, p. 2485-2492.

Research output: Contribution to journalArticlepeer-review

Harvard

Lomivorotov, V, Kornilov, I, Boboshko, V, Shmyrev, V, Bondarenko, I, Soynov, I, Voytov, A, Polyanskih, S, Strunin, O, Bogachev-Prokophiev, A, Landoni, G, Nigro Neto, C, Oliveira Nicolau, G, Saurith Izquierdo, L, Nogueira Nascimento, V, Wen, Z, Renjie, H, Haibo, Z, Bazylev, V, Evdokimov, M, Sulejmanov, S, Chernogrivov, A & Ponomarev, D 2020, 'Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial', JAMA - Journal of the American Medical Association, vol. 323, no. 24, pp. 2485-2492. https://doi.org/10.1001/jama.2020.8133

APA

Lomivorotov, V., Kornilov, I., Boboshko, V., Shmyrev, V., Bondarenko, I., Soynov, I., Voytov, A., Polyanskih, S., Strunin, O., Bogachev-Prokophiev, A., Landoni, G., Nigro Neto, C., Oliveira Nicolau, G., Saurith Izquierdo, L., Nogueira Nascimento, V., Wen, Z., Renjie, H., Haibo, Z., Bazylev, V., ... Ponomarev, D. (2020). Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial. JAMA - Journal of the American Medical Association, 323(24), 2485-2492. https://doi.org/10.1001/jama.2020.8133

Vancouver

Lomivorotov V, Kornilov I, Boboshko V, Shmyrev V, Bondarenko I, Soynov I et al. Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial. JAMA - Journal of the American Medical Association. 2020 Jun 23;323(24):2485-2492. doi: 10.1001/jama.2020.8133

Author

Lomivorotov, Vladimir ; Kornilov, Igor ; Boboshko, Vladimir et al. / Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery : The DECISION Randomized Clinical Trial. In: JAMA - Journal of the American Medical Association. 2020 ; Vol. 323, No. 24. pp. 2485-2492.

BibTeX

@article{be1891f50ac44878b4bbcf6204debd4d,
title = "Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial",
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 1 mg/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 point was a composite of death, nonfatal myocardial 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02615262.",
author = "Vladimir Lomivorotov and Igor Kornilov and Vladimir Boboshko and Vladimir Shmyrev and Ilya Bondarenko and Ilya Soynov and Alexey Voytov and Stanislav Polyanskih and Oleg Strunin and Alexander Bogachev-Prokophiev and Giovanni Landoni and {Nigro Neto}, Caetano and {Oliveira Nicolau}, Gretel and {Saurith Izquierdo}, Leonardo and {Nogueira Nascimento}, Vin{\'i}cius and Zhang Wen and Hu Renjie and Zhang Haibo and Vladlen Bazylev and Mikhail Evdokimov and Shahrijar Sulejmanov and Aleksei Chernogrivov and Dmitry Ponomarev",
note = "Publisher Copyright: {\textcopyright} 2020 American Medical Association. All rights reserved. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",
year = "2020",
month = jun,
day = "23",
doi = "10.1001/jama.2020.8133",
language = "English",
volume = "323",
pages = "2485--2492",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "24",

}

RIS

TY - JOUR

T1 - Effect of Intraoperative Dexamethasone on Major Complications and Mortality among Infants Undergoing Cardiac Surgery

T2 - The DECISION Randomized Clinical Trial

AU - Lomivorotov, Vladimir

AU - Kornilov, Igor

AU - Boboshko, Vladimir

AU - Shmyrev, Vladimir

AU - Bondarenko, Ilya

AU - Soynov, Ilya

AU - Voytov, Alexey

AU - Polyanskih, Stanislav

AU - Strunin, Oleg

AU - Bogachev-Prokophiev, Alexander

AU - Landoni, Giovanni

AU - Nigro Neto, Caetano

AU - Oliveira Nicolau, Gretel

AU - Saurith Izquierdo, Leonardo

AU - Nogueira Nascimento, Vinícius

AU - Wen, Zhang

AU - Renjie, Hu

AU - Haibo, Zhang

AU - Bazylev, Vladlen

AU - Evdokimov, Mikhail

AU - Sulejmanov, Shahrijar

AU - Chernogrivov, Aleksei

AU - Ponomarev, Dmitry

N1 - Publisher Copyright: © 2020 American Medical Association. All rights reserved. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/6/23

Y1 - 2020/6/23

N2 - 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 1 mg/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 point was a composite of death, nonfatal myocardial 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02615262.

AB - 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 1 mg/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 point was a composite of death, nonfatal myocardial 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02615262.

UR - http://www.scopus.com/inward/record.url?scp=85086874705&partnerID=8YFLogxK

U2 - 10.1001/jama.2020.8133

DO - 10.1001/jama.2020.8133

M3 - Article

C2 - 32573670

AN - SCOPUS:85086874705

VL - 323

SP - 2485

EP - 2492

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0098-7484

IS - 24

ER -

ID: 24565957