Abstract 11013: Remote Ischemic Preconditioning in Children Undergoing Surgery with Cardiopulmonary Bypass: A Single Centre Double-Blinded Randomized Trial
Background: Cardiac surgery with cardiopulmonary bypass (CPB) is associated with inflammatory activation and ischemia-reperfusion injury. Remote ischemic preconditioning (RIPC) harnesses an innate defensive mechanism to provide protection. We sought to determine the impact of RIPC on clinical outcomes and physiologic markers related to ischemia-reperfusion injury after cardiac surgery in children.
Methods: Patients ages neonate to 17 years were randomized on the day of surgery to receive an RIPC stimulus (inflation of a BP cuff on the left thigh to 15mmHg above systolic for four 5 minute intervals) or blinded SHAM, during a standardized anesthesia induction. Primary outcome was length of post-op hospital stay (sample size 150 per group to detect 1 day difference), with serial clinical/laboratory measurements for first 48 hours, and clinical follow-up to discharge.
Results: There were no significant baseline differences between RIPC (n=149) and SHAM (n=150), although there was a trend for lower Aristotle score (p=.09) and longer aortic cross-clamping time (p=.09) for RIPC. These two variables, together with a derived propensity score, were used in adjusted comparisons. There were no in-hospital deaths. No significant difference in length of post-op hospital stay was noted (SHAM 5.4 vs. RIPC 5.6 days; diff +0.2; adjusted p=.91), with the 95% CI (-0.7 to +0.9) excluding a pre-specified minimal clinically significant difference of 1 day. There were few significant differences (Table) in other clinical outcomes or values at timepoints/trends in physiologic markers. Benefit was not observed in specific subgroups when explored through interactions with categories of age, sex, surgery type, Aristotle score, or 1st vs. 2nd half of recruitment. Adverse events were similar (SHAM 5%, RIPC 6%; p=.68)
Conclusions: RIPC is not associated with important improvements in clinical outcomes and physiologic markers after cardiac surgery in children.
- © 2011 by American Heart Association, Inc.