Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)

Summary

The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.

Conditions

• Acute Kidney Failure
• Renal Replacement Therapy for Acute Kidney Injury in ICU
• Sedation in Intensive Care Unit Patients
• Sedation in the ICU
• Sedation in Intensive Care
• Blood Pressure
• Mean Arterial Pressure Targets
• Temperature
• Fever
• Resuscitated Sudden Cardiac Death
• Out of Hospital Cardiac Arrest
• Cardiac Arrest (CA)

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, sedation used only as needed to facilitate transport, imaging and invasive procedures

Sponsors & Collaborators

• Helsinki University Central Hospital

  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

2023-08-17

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

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

Study Locations