Table 1_Early use of levosimendan to improve survival and neurological outcomes after cardiac arrest with myocardial dysfunction: a protocol for a randomized controlled trial.docx

The primary outcome is 30-day all-cause mortality, interpreted within an exploratory signal-generating framework. Secondary outcomes explore 30-day neurological recovery assessed by the Cerebral Performance Category (CPC) and Modified Rankin Scale (mRS), along with cardiac function and hemodynamic stability during the first week post-resuscitation.</p>Discussion<p>This exploratory trial is designed to align early levosimendan infusion (within 6 hours post-ROSC) with its pharmacokinetics to cover the anticipated nadir of myocardial dysfunction.

By targeting a homogeneous cohort with witnessed arrest, rapid ROSC (<60 min), and LVEF <40%, the trial focuses on patients with potentially reversible injury who may benefit most. The findings will provide preliminary evidence on efficacy and safety to inform a definitive Phase III trial.</p>Clinical Trial Registration<p>clinicaltrials.gov/study/NCT05956431, ClinicalTrials.gov NCT05956431. Registered on 21 July 2023.</p>