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 'with' 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 patients achieving 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.

Conclusions: EGDT with intermittent ScvO2 monitoring was associated with reduced mortality and improved organ dysfunction in pediatric septic shock.