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

N/AActive Not RecruitingNCT07579390

Helsinki University Central Hospital3,500 enrolled

Overview

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.

The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg. This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital. Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes. All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

3,500

Conditions

Acute Kidney Failure

Interventions

Feedback-controlled temperature deviceDEVICE

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

High MAPOTHER

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

Deep sedationOTHER

Deep sedation for at least 36h

Fever control without a deviceOTHER

Management of fever in the ICU without a device

Low MAPOTHER

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

Minimal sedationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients included to the main STEPCARE-trial are also included to this substudy * Out-of-hospital cardiac arrest * Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions * Unconsciousness (FOUR-score motor response \<4, inability to obey verbal commands), or being intubated and sedated due to agitation * Eligible for intensive care without restrictions or limitations * Inclusion within 4 hours of the return of spontaneous circulation Exclusion Criteria: * Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin * Confirmed or suspected intracranial hemorrhage * Pregnancy * Extracorporeal membrane oxygenation (ECMO) prior to randomization * No additional exclusion criteria are applied beyond those of the main STEPCARE trial

Locations (52)

Princess Alexandra Hospital

Brisbane, Australia

The Prince Charles Hospital

Brisbane, Australia

Nepean Hospital

Kingswood, Australia

Liverpool Hospital

Liverpool, Australia

Austin Hospital

Melbourne, Australia

Royal North Shore Hospital

Outcomes

Primary Outcomes

Major adverse kidney event (MAKE)

A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital

Time frame: 30 days

Secondary Outcomes

Difference between baseline and the highest in-hospital creatinine

Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine

Time frame: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days

Difference between baseline and the last measured in-hospital creatinine

Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)

Time frame: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days

Difference between baseline and 72-hour creatinine

Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine

Time frame: 72 hours

Difference between baseline and the highest creatinine within 72 hours

Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours

Time frame: 72 hours