SQUEEZE Trial: A Trial to Determine whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care
Maternal, Child & Mental Health
The results from SQUEEZE will define the optimal approach to intravascular fluid resuscitation in pediatric septic shock. Results will provide high level evidence to inform future resuscitation guidelines.
OVERALL OBJECTIVE: To determine in pediatric patients with septic shock whether use of a Fluid Sparing strategy results in improved clinical outcomes without an increased risk of adverse events compared to Usual Care.
METHODS: Design: pragmatic, 2-arm, parallel group, open label, multicentre RCT. Sample size: 400 participants. Participants: Children 1 month to 17 yrs with persistent fluid refractory septic shock despite administration of 40 mL/kg (2 litres for ≥ 50 kg) of isotonic crystalloid or colloid. Interventions: Eligible children were randomized to further resuscitation according to 1) Fluid Sparing OR 2) Usual Care.
Primary Outcome: Difference in time to shock reversal between groups.
Secondary Outcomes: 1) Patient Important Clinical Outcomes e.g. PICU Length of Stay, Organ dysfunction scores, Ventilator Free Days, Mortality. 2) Complications attributable to fluid overload and vasoactive medication use. 3) Clinical course and procedures. 4) Health system outcomes e.g. PICU admission rate.
RESULTS: The definitive phase of SQUEEZE enrolled from 2017-2021. Final results include roll-in of pilot trial participants. 1463 were screened and 1057 excluded. 201 were allocated to Fluid Sparing, and 205 to Usual Care. After exclusion of 5 randomization errors, 401 participants were considered further for analysis. Consent for ongoing study participation was obtained for 375/401 (94%), with partial data available for some participants for whom ongoing study participation was declined. A total of 392 participants had data included in the final analysis. At the time of abstract submission, final analysis results are not available.
CONCLUSION: The SQUEEZE Trial was successfully completed. Results expected in 2023.
CHALLENGES/NEXT STEPS: Resuscitation research involving time-sensitive interventions has unique methodological and study process challenges. SQUEEZE produced a high quality dataset. Secondary analyses and papers are planned.
Secondary analyses and papers are planned.