Tight Glycemic Control after Pediatric Cardiac Surgery in High-Risk Patient Populations: A Secondary Analysis of the Safe Pediatric Euglycemia after Cardiac Surgery Trial
Background—Our previous randomized clinical trial showed that post-operative tight glycemic control (TGC) for children undergoing cardiac surgery did not reduce the rate of healthcare-associated infections compared to standard care (STD). Heterogeneity of treatment effect may exist within this population.
Methods and Results—We performed a post-hoc exploratory analysis on 980 children from birth to 36 months at the time of cardiac surgery who were randomized to post-operative TGC or STD in the intensive care unit. Significant interactions were observed between treatment group and both neonate (age ≤30 days, P=0.03) and intraoperative glucocorticoid exposure (P=0.03) on the risk of infection. The rate and incidence of infections in subjects ≤60 days old were significantly increased in the TGC group compared to the STD group (rate 13.5 vs. 3.7 infections/1,000 CICU days, P=0.01; incidence 13% vs. 4%, P=0.02), while infections among those >60 days of age was significantly reduced in TGC compared to STD (rate 5.0 vs. 14.1 infections/1,000 CICU days, P=0.02; incidence 2% vs. 5%, P=0.03); the treatment group by age subgroup interaction was highly significant (P=0.001). Multivariable logistic regression controlling for the main effects revealed that previous cardiac surgery, chromosomal anomaly, and delayed sternal closure were independently associated with increased risk of infection.
Conclusions—This exploratory analysis demonstrated that TGC may lower the risk of infection in children >60 days old at the time of cardiac surgery compared to children receiving STD. Meta-analyses of past and ongoing clinical trials are necessary to confirm these findings before altering clinical practice.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT00443599.
- Received December 13, 2013.
- Revision received January 29, 2014.
- Accepted March 11, 2014.