Early Goal-Directed Therapy With and Without Intermittent Superior Vena Cava Oxygen Saturation Monitoring in Pediatric Septic Shock: A Randomized Controlled Trial.

OBJECTIVE To compare early goal-directed therapy (EGDT) 'With' and 'Without' intermittent superior vena cava oxygen saturation (ScvO2) monitoring in pediatric septic shock. DESIGN Open label randomized controlled trial. SETTING Pediatric intensive care unit in a tertiary care center. PARTICIPANTS Children aged 1 month to 12-year with septic shock. INTERVENTION Patients not responding to fluid resuscitation (up to 40 ml/kg) were randomized to EGDT 'With' (n=59) and 'Without' (n=61) ScvO2 groups. Resuscitation was guided by ScvO2 monitoring at 1-hour, 3-hour, and later on six-hourly in the '' ScvO2 group and by clinical variables in the 'Without' ScvO2 group. OUTCOME Primary outcome was all-cause 28-day mortality. Secondary outcomes were time to and proportion of patient achieved therapeutic endpoints (at 6 hours and PICU stay), need for organ supports, new organ dysfunction (at 24 hours and PICU stay), and length of PICU and hospital stay. RESULTS The study was stopped after interim analysis due to lower mortality in the intervention group. There was significantly lower all-cause 28-day mortality in EDGT with ScvO2 than without ScvO2 group [37.3% vs. 57.5%, adjusted hazard ratio 0.57, 95%CI 0.33 to 0.97, P=0.04]. Therapeutic endpoints were achieved early in 'With' ScvO2 group [mean (SD) 3.6 (1.6) vs. 4.2 (1.6) h, P=0.03]. Organ dysfunction by sequential organ assessment score during PICU stay was lower in with ScvO2 group [median (IQR) 5 (2,11) vs. 8 (3,13); P=0.03]. There was no significant difference in other secondary outcomes. CONCLUSION EGDT with intermittent ScvO2 monitoring was associated with reduced mortality and improved organ dysfunction in pediatric septic shock.