Fifth Centile Versus 50th Centile Mean Blood Pressure Targets in Pediatric Septic Shock: A Randomized Controlled Trial.

Abstract

Objectives: Hypotension is common in septic children, mean blood pressure (MBP) guides vasoactive agent titration. However, the Surviving Sepsis Guidelines for children were unable to recommend whether to target the 5th or 50th MBP percentile for septic shock. We aim to compare two MBP targets (5th vs. 50th percentile) for titrating vasoactive agents in septic shock patients.

Design: Single-center, open-label, randomized noninferiority trial.

Setting: It was conducted in a tertiary care PICU in India from April 2021 to March 2024.

Patients: Patients 1 month to 16 years old with septic shock unresponsive to fluids and requiring vasopressors.

Interventions: Children with septic shock were randomly assigned to either the 5th or 50th percentile MBP group, with vasopressor treatment adjusted to maintain the target blood pressure (BP) for each group.

Measurements and main results: The primary outcome was 28-day all-cause mortality. Secondary outcomes included PICU/hospital stay, duration of vasoactive use, vasopressor-related adverse events, need for continuous renal replacement therapy (CRRT), invasive ventilation, and prevalence of acute respiratory distress syndrome (ARDS). A total of 144 children were enrolled. At 28 days, mortality did not differ significantly between groups: 16.9% (12/71) in the 5th centile group vs. 23.2% (17/73) in the 50th centile group (p = 0.41; risk difference, 6.3; 95% CI, -6.9 to 19.2). Norepinephrine use was higher in the 50th centile group (85% vs. 67%; p = 0.04). Vasoactive duration was longer in the 50th centile group (30.4 ± 13.3 vs. 18.8 ± 10.8; p = 0.001). The Vasoactive-Inotropic Score was also higher (64.0 ± 35.7 vs. 45.2 ± 29.6; p = 0.001). ARDS prevalence was significantly higher in the 50th centile group (32.8% vs. 16.9%; p = 0.02). No significant differences were found in other secondary outcomes like length of stay, ventilation duration, need for CRRT, or adverse events.

Conclusions: Targeting a lower MBP (5th vs. 50th centile) in septic shock showed no significant difference in 28-day mortality. This suggests a lower BP target may be safe, reducing vasoactive drug use and related side effects.