Stress-Dose Corticosteroid Versus Placebo in Neonatal Cardiac Operations: A Randomized Controlled Trial

Suominen, Pertti; Keski‐Nisula, Juho; Ojala, Tiina; Rautiainen, Paula; Jahnukainen, Timo; Hästbacka, Johanna; Neuvonen, Pertti J.; Pitkänen, Olli; Niemelä, Jussi; Kaskinen, Anu; Salminen, Jukka; Lapatto, Risto

doi:10.1016/j.athoracsur.2017.01.111

Cited by 24 publications

(29 citation statements)

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“…The exclusion criteria for patients were prematurity (gestational age <36 weeks), chromosomal abnormalities, administration of corticosteroids before surgery, the need for high preoperative inotropic support, pulmonary malformation, and preoperative acute respiratory symptoms. 8 Fifty-one patients were eligible for the study, but nine patients were excluded because of parental refusal and two according to exclusion criteria. Study patients were randomly assigned to receive either 2 mg/kg MP or placebo (saline) bolus intravenously after the induction of anesthesia, according to a previously published protocol.…”

Section: Patients and Study Designmentioning

confidence: 99%

“…3,4 After pediatric and neonatal congenital cardiac surgery, systemic corticosteroid administration can decrease the systemic inflammatory reaction, but no significant effect on major clinical outcomes, such as mortality, have been demonstrated. [5][6][7][8] The authors' previous study in neonates showed that perioperative intravenous low-dose methylprednisolone (MP) bolus with postoperative stress-dose corticosteroid (SDC) decreased the systemic inflammatory response, stabilized hemodynamics, improved ventricular function, and did not suppress the hypothalamic-pituitary axis after neonatal congenital cardiac surgery with CPB. 8 In children, a combination of preoperative intravenous corticosteroid and intraoperative corticosteroid in CPB prime has improved postoperative oxygen delivery after congenital cardiac surgery with CPB.…”

mentioning

confidence: 99%

“…[5][6][7][8] The authors' previous study in neonates showed that perioperative intravenous low-dose methylprednisolone (MP) bolus with postoperative stress-dose corticosteroid (SDC) decreased the systemic inflammatory response, stabilized hemodynamics, improved ventricular function, and did not suppress the hypothalamic-pituitary axis after neonatal congenital cardiac surgery with CPB. 8 In children, a combination of preoperative intravenous corticosteroid and intraoperative corticosteroid in CPB prime has improved postoperative oxygen delivery after congenital cardiac surgery with CPB. 9,10 However, postoperative inhaled corticosteroids have not affected the pulmonary inflammatory response assessed by cytokine concentrations in the lung lavage, pulmonary mechanics, or oxygenation.…”

mentioning

confidence: 99%

“…To supplement the authors' previously published randomized, double-blinded, placebo-controlled trial, 8 they aimed to evaluate whether neonatal cardiac surgery with CPB induces lung injury and whether SDC treatment prevents postoperative lung injury. The authors hypothesized that SDC treatment in neonates would reduce the risk for postoperative edema, inflammation, and ischemia-reperfusion injury of the lungs and improve postoperative lung function.…”

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confidence: 99%

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Lung Injury After Neonatal Congenital Cardiac Surgery Is Mild and Modifiable by Corticosteroids

Kaskinen

Keski‐Nisula

Martelius

et al. 2021

Journal of Cardiothoracic and Vascular Anesthesia

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Objectives: The present study was performed to determine whether lung injury manifests as lung edema in neonates after congenital cardiac surgery and whether a stress-dose corticosteroid (SDC) regimen attenuates postoperative lung injury in neonates after congenital cardiac surgery. Design: A supplementary report of a randomized, double-blinded, placebo-controlled clinical trial. Setting: A pediatric tertiary university hospital. Participants: Forty neonates (age 28 days) undergoing congenital cardiac surgery with cardiopulmonary bypass. Interventions: After anesthesia induction, patients were assigned randomly to receive intravenously either 2 mg/kg methylprednisolone or placebo b, which was followed by hydrocortisone or placebo bolus six hours after weaning from CPB for five days as follows: 0.2 mg/kg/h for 48 hours, 0.1 mg/kg/h for the next 48 hours, and 0.05 mg/kg/h for the following 24 hours. Measurements and Main Results: The chest radiography lung edema score was lower in the SDC than in the placebo group on the first postoperative day (POD one) (p = 0.03) and on PODs two and three (p = 0.03). Furthermore, a modest increase in the edema score of 0.9 was noted in the placebo group, whereas the edema score remained at the preoperative level in the SDC group. Postoperative dynamic respiratory system compliance was higher in the SDC group until POD three (p < 0.01). However, postoperative oxygenation; length of mechanical ventilation; and tracheal aspirate biomarkers of inflammation and oxidative stress, namely interleukin-6, interleukin-8, resistin, and 8-isoprostane, showed no differences between the groups. Conclusions: The SDC regimen reduced the development of mild and likely clinically insignificant radiographic lung edema and improved postoperative dynamic respiratory system compliance without adverse events, but it failed to improve postoperative oxygenation and length of mechanical ventilation.

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Section: Patients and Study Designmentioning

confidence: 99%

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confidence: 99%

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Lung Injury After Neonatal Congenital Cardiac Surgery Is Mild and Modifiable by Corticosteroids

Kaskinen

Keski‐Nisula

Martelius

et al. 2021

Journal of Cardiothoracic and Vascular Anesthesia

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“…However, some potential adverse effects may be associated with corticosteroids, for example, hyperglycemia, poor wound healing, infections, and poor neurodevelopmental outcomes (6)(7)(8). Several small, randomized, controlled studies in pediatric patients have investigated the effect of perioperative corticosteroids on the inflammatory biomarkers, clinical outcomes, and adverse events after congenital heart surgeries (9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25). Nevertheless, the results were conflicted, resulting in the controversy over perioperative corticosteroids.…”

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confidence: 99%

Perioperative Corticosteroid Therapy in Children Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis

Luo

et al. 2020

Front. Pediatr.

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Background: The benefit-risk profile of perioperative corticosteroids in pediatric patients undergoing cardiac surgery remains controversial. Objective: To investigate the influence of perioperative corticosteroids on the postoperative mortality and clinical outcomes in pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Methods: We conducted a systematic search using MEDLINE, EMBASE, and Cochrane Database through August 31, 2019. We included randomized controlled trials comparing perioperative corticosteroids with other clinical interventions, placebo, or no treatment in children between 0 and 18 years of age undergoing cardiac surgery. The primary outcome of interest was all-cause in-hospital mortality. The secondary outcomes were length of intensive care unit stay (LOIS), duration of mechanical ventilation (DMV), postoperative insulin therapy, postoperative low cardiac output syndrome (LCOS), postoperative infection, maximal temperature (T max) in the first 24 h postoperatively, urine output (UO) in the first 24 h postoperatively, serum lactate at postoperative day (POD) 1, blood glucose at POD 1, vasoactive inotrope score (VIS) at POD 1, and postoperative acute kidney injury (AKI). Study quality was assessed using the Cochrane Risk of Bias Assessment Tool. Results: Our analysis included 17 studies and 848 pediatric patients. The data demonstrated that children receiving corticosteroids showed no significant difference on the all-cause in-hospital mortality with a fixed-effect model (RR = 0.59, 95% CI = 0.28-1.25, P = 0.55) compared with controls. For the secondary outcomes, corticosteroids had a statistically significant reduction on the VIS at POD1 (MD = −2.04, 95% CI = −3.96 −0.12, P = 0.04), while it might be significantly associated with an increased blood glucose at POD1 (MD = 1.38, 95% CI = 0.68-2.09, P = 0.0001) and a 2.69-fold higher risk of postoperative insulin therapy (RR = 2.69, 95% CI = 1.37-5.27, P = 0.004). No statistical significance was shown in other secondary outcomes. Conclusion: Perioperative corticosteroids might not significantly improve clinical outcomes identified as mortality, LOIS, DMV, AKI, and LCOS other than VIS at Li et al. Corticosteroids in Pediatric Cardiac Surgery POD1. However, it might increase the blood glucose and episodes of insulin therapy. Perioperative corticosteroids to attenuate the inflammatory response are not supported by available evidence from our study. Further results from ongoing randomized controlled trials with a larger sample size are required.

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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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Stress-Dose Corticosteroid Versus Placebo in Neonatal Cardiac Operations: A Randomized Controlled Trial

Abstract: The SDC regimen for 5 days postoperatively in neonates was safe and did not cause suppression of the hypothalamic-pituitary-adrenal axis. Furthermore, the open heart operation per se did not lead to adrenal insufficiency in neonates.

Cited by 24 publications

References 27 publications

Lung Injury After Neonatal Congenital Cardiac Surgery Is Mild and Modifiable by Corticosteroids

Lung Injury After Neonatal Congenital Cardiac Surgery Is Mild and Modifiable by Corticosteroids

Perioperative Corticosteroid Therapy in Children Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis

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

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