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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Deep sedation: Deep sedation for at least 36h

Fever control without a device: Management of fever in the ICU without a device

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Major adverse kidney event (MAKE) — 30 days
  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

Trial sites (52)

+ 12 more sites — see the full list on the official registry below.

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