Epinephrine Plus Vasopressin vs Epinephrine Plus Placebo in Pediatric Intensive Care Unit Cardiopulmonary Resuscitation: A Randomized Double Blind Controlled Clinical Trial.

OBJECTIVE To compare the efficacy of Epinephrine plus Vasopressin versus Epinephrine plus Placebo in the pediatric intensive care unit (PICU) cardiopulmonary resuscitation (CPR). DESIGN Randomized, double-blind controlled clinical trial. SETTING PICU in a tertiary care institute from February 2019 to May 2020. PARTICIPANTS Children aged one month to 13 years who required CPR during PICU stay. Patients in whom vascular access was not available or return of spontaneous circulation (ROSC) was achieved by defibrillation without Epinephrine were excluded. INTERVENTION Patients were randomized to receive Vasopressin 0.1 mL per kg (=0.8 Unit per kg) or Placebo (0.1 mL per kg normal saline) in addition to Epinephrine (1:10000) 0.1 mL per kg. The drugs were given as bolus doses every three minutes until the ROSC or up to a maximum of five doses, whichever was earlier. OUTCOME MEASURE The primary outcome was the proportion of patients who achieved ROSC. The secondary outcomes were survival rate and functional status (at 24-hour, PICU, hospital, and 90-day post-discharge), need for organ supports, length of stay (PICU and hospital), and adverse effect(s) of the study drugs. RESULT Ninety patients (Epinephrine plus Vasopressin group n=45 and Epinephrine plus Placebo group n=45) were analyzed on the "intention to treat" basis. There was no significant difference in the primary outcome between Epinephrine plus Vasopressin (n=25, 55.5%) and Epinephrine plus Placebo groups (n=24, 53.3%) (Relative risk 1.04, 95% CI 0.71 to 1.52). There was no significant difference in survival rate at 24-hour (n=7, 15.6% vs. n=8, 17.8%), at PICU, hospital, and 90-day post-discharge (n=1, 2.2% vs. n=1, 2.2%). There was no difference in other secondary outcomes. No trial drug-related serious adverse events were observed. CONCLUSION A combination of Epinephrine plus Vasopressin did not improve the rate of return of spontaneous circulation in the pediatric intensive care unit cardiopulmonary resuscitation as compared with Epinephrine plus Placebo.