Objective
To evaluate all published pediatric randomized controlled trials (RCTs) of patients with septic shock from any cause to examine the outcome measures used, the strengths and limitations of these measurements and whether the trial outcomes met feasibility criteria.
Data source
We used a previously published database of pediatric critical care RCTs (PICUtrials.net) derived from searches of MEDLINE, EMBASE, LILACS and CENTRAL.
Study selection
We included RCTs of interventions to children admitted to a pediatric intensive care unit (PICU) with septic or dengue hemorrhagic shock which were published in English.
Data extraction
Study characteristics and outcomes were retrieved by two independent reviewers with disagreement being resolved by a third reviewer. We defined feasibility as 1) recruitment of at least 90% of the targeted sample size and agreement of the observed outcome rate in the control group with the rate used for the sample size calculation to within 10% or 2) finding of a statistically significant difference in an interim or final analysis.
Data synthesis
Nineteen of 321 identified articles were selected for review. Fourteen of 19 studies (74%) provided an a priori definition of their primary outcome measure in their methods section. Mortality rate was the most commonly reported primary outcome (8/14, 57%), followed by duration of shock (4/14, 29%) followed by organ failure (1/14, 7%). Only 3 of 19 included trials met feasibility criteria.
Conclusions
Our review found that use of mortality alone as a primary outcome in pediatric septic shock trials was associated with significant limitations and that long-term patient centered outcomes were not utilized in this setting. Composite outcomes incorporating mortality and long-term outcomes should be explored for use in future pediatric septic shock trials.