Protocolized Evaluation of Permissive Blood Pressure Targets Versus Usual Care (PRESSURE): Statistical Analysis Plan for the PRESSURE Trial.

OBJECTIVE

To describe the prespecified analysis plan for Protocolized Evaluation of Permissive Blood Pressure Targets vs. Usual Care (PRESSURE), a trial comparing a permissive mean arterial pressure (MAP) target above the age-specific fifth centile with usual care in critically ill children.

DESIGN

Pragmatic, open, multicenter, parallel group randomized controlled trial with integrated economic evaluation.

SETTING

Twenty-one PICUs in the United Kingdom.

PATIENTS: Infants and children older than 38 weeks corrected gestational age to 16 years, accepted to a participating PICU, on invasive mechanical ventilation (IMV) and receiving vasoactive drugs for hypotension.

INTERVENTION: Adjustment of hemodynamic support to achieve a permissive MAP target greater than the fifth centile for age during IMV.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome is a composite 30-day mortality and duration of IMV, and it will be analyzed with a two-sample rank-sum test. Components will also be analyzed separately. Sensitivity analyses will adjust for adherence, and subgroup analyses will test interactions with baseline covariates. Secondary analyses will compare mortality at various time-points, duration of survival, time to liberation from IMV, functional status changes, receipt of renal replacement therapy and length of stay. The health economic analysis will follow the intention-to-treat principle and report the mean (95% CI) incremental costs, quality-adjusted life years and cost-effectiveness up to 12 months.

CONCLUSIONS

Results will be reported following this plan through peer-reviewed publications and conference presentations.