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Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

NCT05564754 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2025-07-15

No results posted yet for this study

Summary

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

Conditions

  • Cardiac Arrest With Successful Resuscitation
  • Hypoxia, Brain

Interventions

DEVICE

Feedback-controlled temperature device

If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.

OTHER

High MAP

A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.

OTHER

Deep sedation

Deep sedation for at least 36h

OTHER

Fever control without a device

Management of fever in the ICU without a device

OTHER

Low MAP

A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.

OTHER

Minimal sedation

A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.

Sponsors & Collaborators

  • Lund University, Lund, Sweden

    collaborator UNKNOWN

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • The George Institute for Global Health, Australia

    collaborator OTHER

  • HUS Helsinki University Hospitals, Helsinki, Finland

    collaborator UNKNOWN

  • Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand

    collaborator UNKNOWN

  • University Hospital of Wales

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Niklas Nielsen, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Australia
  • Belgium
  • Estonia
  • Finland
  • Germany
  • Ireland
  • Italy
  • Luxembourg
  • New Zealand
  • Norway
  • Saudi Arabia
  • Singapore
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564754 on ClinicalTrials.gov