STEPCARE: Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation

Background

Survival from cardiac arrest that occurs in the community setting remains low, and treatment after cardiac arrest requires further optimisation.  After successful resuscitation, patients who survive a cardiac arrest often remain severely ill and require intensive care; and those who recover may have new impairment of health including physical and brain function. Management of sedation, body temperature and blood pressure during intensive care, are potential strategies to improve brain and physical health; and the STEPCARE trial aims to determine the most effective approach to these interventions.

Among survivors discharged from hospital, around 50% experience some degree of physical or cognitive impairment, which is associated with reduced quality of life and increased caregiver burden.  Even  modest improvements in the proportion of patients achieving good neurological outcome after out-of-hospital cardiac arrest could have a substantial impact on thousands of lives. While numerous interventions have been evaluated to reduce mortality and improve neurological outcomes, translation of promising experimental findings into consistent clinical benefit has been challenging.

The STEPCARE trial, with 3500 participants recruited internationally, represents the largest study to date of ICU management after cardiac arrest.

Please refer to the following website for further information: https://stepcare.org/

Aim

STEPCARE trial will aim to strengthen the evidence for managing sedation, body temperature and mean arterial pressure, with the goal of improving outcomes for patients following a cardiac arrest. 

The primary outcome is survival at 180 days, with secondary outcomes including neurological function and health-related quality of life.

Research Methodology

The STEPCARE trial is an international, investigator-initiated, randomized trial evaluating three key aspects of standard care following out-of-hospital cardiac arrest. Using a 2x2x2 factorial design, the trial compares continuous or minimal sedation, fever management with or without a device and higher versus lower blood pressure targets.

Eligible patients will be unconscious adult patients resuscitated from out-of-hospital cardiac arrest and have achieved stable return of spontaneous circulation. All patients will be randomized across three intervention comparisons.

The three comparisons are:

• Continuous sedation for 36 hours or a minimal sedation strategy
• Fever management with or without a feedback-controlled device
• A mean arterial pressure target of >85 mmHg or >65 mmHg

Randomization will be performed by a healthcare professional in the ICU via web-based application using permuted blocks with varying sizes, stratified by site.

Due to the nature of the interventions, treating clinicians and participants cannot be blinded. However, outcome assessors, neurological prognosticators, statisticians, and members of the management and steering committees, as well as authors, will remain blinded to group allocation.

Participants will be followed-up at 30 days, and at 6 and 12 months after cardiac arrest. The main results will be published after completion of the 6-month follow-up, with each strategy reported separately.
Across more than 50 international sites, Australia contributed eight participating sites, accounting for approximately 10% of total trial recruitment.

Current Status

Recruitment completed May 2026, 6 month follow-up will complete in November-December 2026.

• A total of 3,500 participants were recruited internationally
• Of these, 360 participants were recruited in Australia

Data cleaning, analysis and manuscript writing will soon commence.