2026-10-13T06:57:51Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33870820 2026-09-17T04:28:24Z category_140 portal_316 item_type_3 month_year_09_2026

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 Zhen De (25001578) Nengyuan Xu (25001581) Hua Zhang (12549) Fan Yang (1413) Lanfang Du (11915852) Cardiology cardiac arrest levosimendan myocardial dysfunction post-cardiac arrest syndrome randomized controlled trial Introduction<p>Post-cardiac arrest myocardial dysfunction (PAMD) is a major contributor to early death (within 72 hours) following return of spontaneous circulation (ROSC). Levosimendan, a calcium-sensitizing inotrope with vasodilatory and mitochondrial-protective properties, offers a potential therapeutic strategy by increasing cardiac output, improving organ perfusion, and attenuating mitochondrial ischemia-reperfusion injury. While experimental evidence suggests multi-organ benefits in cardiac arrest (CA), robust clinical data are lacking.</p>Methods and analysis<p>This exploratory, partially blinded, randomized, placebo-controlled trial will enroll 60 comatose CA patients with PAMD across three centers in China. Within 180 minutes after ROSC, eligible participants will be randomized (1:1) to receive either intravenous levosimendan (0.05–0.2 μg/kg/min for 24 hours) or volume-matched saline placebo; the assigned infusion will begin within 6 hours after ROSC. 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>https://clinicaltrials.gov/study/NCT05956431, ClinicalTrials.gov NCT05956431. Registered on 21 July 2023.</p> 2026-09-17T04:28:24Z Dataset Dataset 10.3389/fcvm.2026.1850394.s001 https://figshare.com/articles/dataset/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/33870820 CC BY 4.0