Stepcare Extended Follow-up Substudy

Summary

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

Conditions

• Cardiac Arrest With Successful Resuscitation
• Hypoxia, Brain
• Cognitive Impairment
• Caregiver Burden

Interventions

DEVICE

Feed back controlled temperature device

If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius

OTHER

High MAP

A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours

OTHER

Deep sedation

Deep sedation for at least 36 hours

OTHER

Fever control without a device

Management of fever in the intensive care unit without a device

OTHER

Low MAP

A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours

OTHER

Minimal sedation

A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• The George Institute for Global Health, Australia

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Region Skane

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2027-01-31

Completion

2027-07-31

Countries

• Australia
• Belgium
• Finland
• Germany
• Luxembourg
• New Zealand
• Norway
• Sweden
• Switzerland
• United Kingdom

Study Locations