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Standardized preoperative corticosteroid treatment in neonates undergoing cardiac surgery: results from a randomized trial.

ABSTRACT: A heightened inflammatory response occurs after cardiac surgery. The perioperative use of glucocorticoids has been advocated as a method to improve postoperative outcomes. Randomized prospective studies to quantify the effect of methylprednisolone on perioperative outcomes in neonatal cardiac surgery have not been performed. We sought to determine whether preoperative methylprednisolone would improve postoperative recovery in neonates requiring cardiac surgery.Neonates scheduled for cardiac surgery were randomly assigned to receive either 2-dose (8 hours preoperatively and operatively, n = 39) or single-dose (operatively, n = 37) methylprednisolone (30 mg/kg per dose) in a prospective double-blind trial. The primary outcome was the incidence of low cardiac output syndrome (standardized score) or death 36 hours postoperatively. Secondary outcomes were death at 30 days, interleukin-6 levels, inotropic score, fluid balance, serum creatinine, and intensive care unit and hospital stay.Preoperative plasma levels of the inflammatory cytokine interleukin-6 were reduced by 2-fold (P < .001) in the 2-dose methylprednisolone group, consistent with the anti-inflammatory effects of methylprednisolone. However, the incidence of low cardiac output syndrome was 46% (17/37) in the single-dose and 38% (15/39) in the 2-dose methylprednisolone groups (P = .51). Two-dose methylprednisolone was associated with a higher serum creatinine (0.61 ± 0.18 mg/dL vs 0.53 ± 0.12 mg/dL, P = .03) and poorer postoperative diuresis (-96 ± 49 mL, P = .05). Inotropic requirement, duration of mechanical ventilation, intensive care unit, and hospital stay did not differ between the 2 groups.Combined preoperative and intraoperative use of glucocorticoids in neonatal cardiac surgery does not favorably affect early clinical outcomes and may exacerbate perioperative renal dysfunction.

SUBMITTER: Graham EM

PROVIDER: S-EPMC3161127 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Standardized preoperative corticosteroid treatment in neonates undergoing cardiac surgery: results from a randomized trial.

Graham Eric M EM Atz Andrew M AM Butts Ryan J RJ Baker Nathaniel L NL Zyblewski Sinai C SC Deardorff Rachael L RL DeSantis Stacia M SM Reeves Scott T ST Bradley Scott M SM Spinale Francis G FG

The Journal of thoracic and cardiovascular surgery 20110520 6

<h4>Objective</h4>A heightened inflammatory response occurs after cardiac surgery. The perioperative use of glucocorticoids has been advocated as a method to improve postoperative outcomes. Randomized prospective studies to quantify the effect of methylprednisolone on perioperative outcomes in neonatal cardiac surgery have not been performed. We sought to determine whether preoperative methylprednisolone would improve postoperative recovery in neonates requiring cardiac surgery.<h4>Methods</h4>N ...[more]

PMID: 21600592

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Project description:BackgroundThe efficacy of intraoperative corticosteroids to improve outcomes following congenital cardiac operations remains controversial.ObjectivesThe purpose of this study was to determine whether intraoperative methylprednisolone improves post-operative recovery in neonates undergoing cardiac surgery.MethodsNeonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers were enrolled in a double-blind randomized controlled trial of methylprednisolone (30 mg/kg) or placebo after the induction of anesthesia. The primary outcome was a previously validated morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (>5 mmol/l).ResultsOf the 190 subjects enrolled, 176 (n = 81 methylprednisolone, n = 95 placebo) were included in this analysis. A total of 27 (33%) subjects in the methylprednisolone group and 40 (42%) in the placebo group reached the primary study endpoint (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.31 to 1.3; p = 0.21). Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048). There was a significant interaction between treatment effect and center. In this analysis, methylprednisolone was protective at 1 center, with an OR: 0.35 (95% CI: 0.15 to 0.84; p = 0.02), and not so at the other center, with OR: 5.13 (95% CI: 0.85 to 30.90; p = 0.07).ConclusionsIntraoperative methylprednisolone failed to show an overall significant benefit on the incidence of the composite primary study endpoint. There was, however, a benefit in patients undergoing palliative procedures and a significant interaction between treatment effect and center, suggesting that there may be center or patient characteristics that make prophylactic methylprednisolone beneficial.

Project description:ObjectiveTo establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial.DesignPilot randomized controlled trial.SettingRoyal Prince Alfred Hospital, Sydney, Australia.SubjectsWe included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the participating gastrointestinal surgeon at least 2 weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded.MethodsParticipants were randomized to a 2-6 weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital.ResultsOf 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63 years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups.ConclusionsThe results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs.Trial registrationACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true.

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Standardized preoperative corticosteroid treatment in neonates undergoing cardiac surgery: results from a randomized trial.

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Standardized preoperative corticosteroid treatment in neonates undergoing cardiac surgery: results from a randomized trial.

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