Abstract
Although commonly used in pediatric cardiopulmonary bypass (CPB) optimal dose and timing of steroid administration is unclear. We hypothesized that early administration of a commonly used dose of methylprednisolone given the evening before surgery (ultra-early) would be more effective in decreasing CPB-related inflammatory response than when given at induction of anesthesia (early) or in pump prime (standard).This was a triple-arm, parallel, active control, superiority RCT including 54 infants <2 years old who were randomised to receive 30 mg/kg methylprednisolone at one of the 3 time points. Outcomes included alveolar-arterial oxygen gradient (AaDO2) during, 24, 48 and 72 hours post-CPB, IL-6, IL-8 and reduced (GSH) to oxidized (GSSG) glutathione ratio (pre-ultrafiltration on CPB, end-CPB and 24 hours), PICU length of stay (LOS) and ventilator days. Data were analysed using descriptive statistics and a random effects regression model.The ultra-early group had higher Risk Adjusted Congenital Heart Surgery Score, lower age and longer CPB times than the other groups. No significant differences in AaDO2, IL-8, PICU LOS and ventilator days were observed between groups. Compared to the ultra-early group, the overall rise in IL-6 in the early and standard groups was lower, -27.8 pg/ml (95% CI -52.7,-2.9) and -35.3 pg/ml (95% CI -64.3,-6.34), respectively. GSH:GSSG was significantly lower in the standard group (-35.9; 95% CI -63.31,-8.5) at 24 hours post-CPB.Ultra-early administration of methylprednisolone does not improve AaDO2 post-CPB, nor diminish cytokine release. Lower GSH:GSSG in the standard group suggests less oxidative stress. However despite statistical adjustments conclusions are limited by the unbalanced randomisation of the groups.
Highlights
The use of corticosteroids as a means of diminishing the inflammatory response to cardiopulmonary bypass (CPB) has become a standard of practice in many institutions (Jonas 2004)
We performed this study with the objective of testing the hypothesis that a single ultraearly dose of methylprednisolone (the evening preceding surgery (Clarizia et al 2011)) would improve A-aDO2 and other clinical and biochemical outcome measures compared to early or standard administration in children aged less than 2 years undergoing corrective congenital cardiac surgery
There were 2 protocol violations: 1) methylprednisolone 30 mg/kg was given 8 hours before surgery instead of study dose 1; 2) methylprednisolone 30 mg/kg was given at induction instead of study dose 2
Summary
The use of corticosteroids as a means of diminishing the inflammatory response to cardiopulmonary bypass (CPB) has become a standard of practice in many institutions (Jonas 2004). Two studies performed in humans investigated the effect of two doses of corticosteroids on CPB-induced inflammatory response, one of them given pre-operatively (Schroeder et al 2003; Graham 2011). It remains unclear if the benefits observed in these studies are due to early administration of corticosteroids or use of two doses. We performed this study with the objective of testing the hypothesis that a single ultraearly dose of methylprednisolone (the evening preceding surgery (Clarizia et al 2011)) would improve A-aDO2 and other clinical and biochemical outcome measures compared to early (at anesthesic induction, 1–2 hours pre-CPB) or standard (during CPB) administration in children aged less than 2 years undergoing corrective congenital cardiac surgery
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