P0191 / #1905: RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL ON EPINEPHRINE PLUS VASOPRESSIN VERSUS EPINEPHRINE PLUS PLACEBO IN PEDIATRIC INTENSIVE CARE CARDIOPULMONARY RESUSCITATION

Abstract

Aims & Objectives: The primary outcome was to see the proportion of patients who achieved ROSC. The secondary outcomes were (i) survival rate (at 24 hours, PICU, hospital, and 90-day of discharge), (ii) functional status (at PICU, hospital, and 90-day of discharge), (iii) need for organ support(s), (iv) length of stay in PICU and hospital, (v) the number of cardiac arrests, and (vi) adverse effect(s) of the study drugs if any. Methods: Patients were randomized to receive Vasopressin 0.1 mL per kg (=0.8 IU 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 return of spontaneous circulation (ROSC) was achieved or a maximum of five doses, whichever was earlier. Patients in whom vascular access was not available or ROSC was achieved by defibrillation without Epinephrine were excluded. Results: 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 difference in the primary outcome between Epinephrine plus Vasopressin (55.5%), and Epinephrine plus Placebo groups (53.3%) (Relative risk 1.04, 95% CI 0.71 to 1.52; adjusted hazard ratio 0.56, 95% CI 0.29 to 1.08). There was no difference in survival rate at 24-hour (15.6% vs. 17.8%), at PICU, hospital, and 90-day post-discharge (2.2% vs. 2.2%). The number of cardiac arrests that required the study drugs was lower in Epinephrine plus Vasopressin group [median (IQR) 1, 1 – 1 vs. 1.5, 1 – 3; P=0.011]. No difference in other secondary outcomes was noted. Conclusions: A combination of Epinephrine plus Vasopressin did not improve the return of spontaneous circulation in pediatric intensive care cardiac arrest resuscitation.