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Protocol for a Randomized Controlled Trial to Evaluate a Permissive Blood Pressure Target Versus Usual Care in

Robert Darnell1, Alanna Brown1, Emma Laing1

  • 1Clinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, United Kingdom.

Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
|April 17, 2024
PubMed

Insights

The PRESSURE trial investigates if a permissive mean arterial pressure (MAP) target improves outcomes for hypotensive children in pediatric intensive care units (PICUs). This study compares a lower MAP target to usual care to determine clinical and cost-effectiveness.

Area of Science:

  • Pediatric Critical Care Medicine
  • Pediatric Cardiology
  • Clinical Trial Design

Background:

  • Hypotension management is crucial in pediatric critical care.
  • Current optimal blood pressure targets for hypotensive children are not well-defined.
  • Vasoactive drugs and fluids are standard treatments for pediatric hypotension.

Purpose of the Study:

  • To evaluate the clinical and cost-effectiveness of a permissive mean arterial pressure (MAP) target in pediatric patients.
  • To compare a permissive MAP target (greater than the fifth centile for age) against usual care in hypotensive children.
  • To assess the impact of different blood pressure management strategies on patient outcomes.

Main Methods:

  • A pragmatic, open-label, multicenter, parallel-group randomized control trial (RCT) with an integrated economic evaluation.
  • The study includes infants and children aged 37 weeks corrected gestational age to 16 years admitted to 18 UK PICUs, on mechanical ventilation and receiving vasoactive drugs.
  • Intervention involves adjusting hemodynamic support to achieve a permissive MAP target greater than the fifth centile for age.

Main Results:

  • The primary outcome is a composite of death and days of ventilatory support within 30 days.
  • Patients are randomized 1:1 to either a permissive MAP target or usual care.
  • Data collected include baseline demographics, clinical status, daily blood pressure, organ support measures, and discharge outcomes.

Conclusions:

  • The findings of the PRESSURE trial will provide evidence on the optimal blood pressure management in critically ill children.
  • Dissemination of results is planned through national and international conferences and peer-reviewed publications.
  • The study aims to inform clinical practice guidelines for pediatric hypotension management.
Abstract

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