Study design and population
deaths, CHUV, post-cardiac arrest shock
CARDIAC ARREST
This pilot single-center open-label randomized controlled trial was conducted in the Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. We considered for inclusion all adult patients admitted to our institution’s intensive care unit (ICU) following in- or out-of-hospital cardiac arrest. Those who presented one of the following criteria within 24 h of admission were eligible: time-to-ROSC > 25 min and/or serum lactate level > 6 mmol/l and/or need for norepinephrine > 0.2 µg/kg/min for ≥ 1 h to maintain mean arterial pressure (MAP) > 60–70 mmHg. In the absence of a consensual definition for PCAS, these criteria were chosen based on their association with IL-6 plasma levels or post-cardiac arrest shock, a major feature of PCAS accounting for most deaths within the first 3 days [Since eligible patients were expected to be unable to provide informed consent prior to randomization and since the intervention could not be delayed, an emergency consent procedure was performed. According to this procedure, patients without documented refusal to participate in clinical trials could be included pending the approval of a physician independent from the trial. Consent from a proxy was sought as soon as possible as well as from the patient himself once able to provide informed consent. The study protocol was approved by the Ethics Committee of Vaud (2018-00421) and registered at ClinicalTrials.gov (NCT03523039).