Dexamethasone in pEdiatric Cardiac Surgery (DECiSion): Rationale and design of a randomized controlled trial

Ponomarev, Dmitry; Boboshko, Vladimir; Shmyrev, Vladimir; Kornilov, Igor; Bondarenko, Ilya; Soynov, Ilya; Voytov, A.V.; Polyanskih, Stanislav; Струнин, О. В.; Bogachev, Alexander V.; Landoni, Giovanni; Neto, Caetano Nigro; Nicolau, Gretel Oliveira; Wen, Zhang; Евдокимов, М. Е.; Sulejmanov, Shahrijar; Черногривов, А.Е.; Караськов, А. М.; Lomivorotov, Vladimir V.

doi:10.1016/j.cct.2018.07.005

Cited by 2 publications

(2 citation statements)

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“…The trial protocol, including the statistical analysis plan, available in Supplement 1. The trial design has been previously published …”

Section: Methodsmentioning

confidence: 99%

“…The trial design has been previously published. 14 Eligible patients were infants 12 months or younger, scheduled for elective cardiac surgery with cardiopulmonary bypass. Patients were excluded if they needed emergency surgery; had hypoplastic left heart syndrome; used of steroids or inotropes; had confirmed infection within 30 days, severe perinatal central nervous system damage, gestational age younger than 37 weeks, mechanical ventilation, or use of inotropes prior to surgery; or were participating in conflicting trials.…”

Section: Trial Design and Settingmentioning

confidence: 99%

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Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery

Ломиворотов

Kornilov

Boboshko

et al. 2020

JAMA

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IMPORTANCECorticosteroids 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 PARTICIPANTSThe 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. INTERVENTIONSThe 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 MEASURESThe 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.

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“…The trial protocol, including the statistical analysis plan, available in Supplement 1. The trial design has been previously published …”

Section: Methodsmentioning

confidence: 99%

Section: Trial Design and Settingmentioning

confidence: 99%

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery

Ломиворотов

Kornilov

Boboshko

et al. 2020

JAMA

Self Cite

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Prolonged Extracorporeal Circulation Leads to Inflammation and Higher Expression of Mediators of Vascular Permeability Through Activation of STAT3 Signaling Pathway in Macrophages

Luecht,

Pauli,

Seiler

et al. 2024

IJMS

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Congenital heart defects (CHDs) are one of the most common congenital malformations and often require heart surgery with cardiopulmonary bypass (CPB). Children undergoing cardiac surgery with CPB are especially at greater risk of post-operative complications due to a systemic inflammatory response caused by innate inflammatory mediators. However, the pathophysiological response is not fully understood and warrants further investigation. Therefore, we investigated the inflammatory response in macrophages initiated by peri-operative serum samples obtained from patients with CHD undergoing CPB cardiac surgery. Human differentiated THP-1 macrophages were pretreated with Stattic, a STAT3 (Tyr705) inhibitor, before stimulation with serum samples. STAT3 and NF-κB activation were investigated via a Western blot, IL-1β, TNFα, IL-10, mediators for vascular permeability (VEGF-A, ICAM), and SOCS3 gene expressions via RT-qPCR. CPB induced an inflammatory response in macrophages via the activation of the STAT3 but not NF-κB signaling pathway. Longer duration on the CPB correlated with increased cytokine, VEGF, and ICAM expressions, relative to individual pre-operation levels. Patients that did not require CPB showed no significant immune response. Pretreatment with Stattic significantly attenuated all inflammatory mediators investigated except for TNFα in the macrophages. CPB induces an increased expression of cytokines and mediators of vascular permeability via the activation of STAT3 by IL-6 and IL-8 in the serum samples. Stattic attenuates all mediators investigated but promotes TNFα expression.

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Dexamethasone in pEdiatric Cardiac Surgery (DECiSion): Rationale and design of a randomized controlled trial

Cited by 2 publications

References 18 publications

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery

Prolonged Extracorporeal Circulation Leads to Inflammation and Higher Expression of Mediators of Vascular Permeability Through Activation of STAT3 Signaling Pathway in Macrophages

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