Early Versus Late Wake-Up Call After Out-Of-Hospital Cardiac Arrest: Protocol for a Multicenter Randomized Comparison Within the Danish Out-of-Hospital Cardiac Arrest (DANOHCA) Trial.

Abstract

Survivors of out-of-hospital cardiac arrest (OHCA) who remain comatose after return of spontaneous circulation are routinely sedated and mechanically ventilated during early post-resuscitation care. Although prolonged sedation has traditionally been considered necessary, contemporary normothermia-based temperature control allows earlier wake-up call. The optimal timing of an early wake-up call remains unknown and may influence overall mortality, neurological recovery, duration of mechanical ventilation, and length of hospital stay. The Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial (clinicaltrials.gov identifier: NCT05895838; and euclinicaltrials.eu, identifier: 2024-515,997-28-00) is an investigator-initiated, multicenter, randomized clinical trial using a 2 × 2 × 2 × 2 factorial design evaluating four interventions in patients resuscitated from OHCA. The present protocol describes the comparison of an early versus late wake-up call strategy. Adult patients (≥ 18 years) with presumed cardiac-cause of OHCA, sustained return of spontaneous circulation, and persistent unconsciousness on intensive care unit admission are randomized 1:1 to early wake-up call (≤ 6 h after randomization) or late wake-up call (28-36 h after randomization). Wake-up call includes interruption of sedation, assessment of neurology, and may be followed by extubation if predefined neurological and respiratory criteria are fulfilled. The primary endpoint is days alive and out of hospital within 30 days after randomization. Analyses will follow a modified intention-to-treat principle. Optimizing post-resuscitation care remains a cornerstone in managing comatose cardiac arrest survivors and improving outcomes. We hypothesize that sedation for 28-36 h leads to more days alive outside of the hospital in 30 days compared to sedation for ≤ 6 h. EudraCT number: 2016-003265-26; EU CTIS no 2024-515997-28-00; ClinicalTrials.gov identifier: NCT05895838.