RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Heart Arrest

Treatments: Drug: Levosimendan Injection; Drug: physiological saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05956431

M2023327

Details and patient eligibility

About

This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1: Age>18 years old

  2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes

  3: Patients with witnessed cardiac arrest

  4: ROSC lasts for less than 60 minutes

  5: Low cardiac output syndrome after ROSC (LVEF<40%)

  6: Still in a coma after ROSC, Glasgow score<8 points

  7: Complete enrollment within 180 minutes after ROSC

Exclusion criteria

• 1: Patients receiving extracorporeal Cardiopulmonary resuscitation

  2: Patients with severe neurological deficits prior to cardiac arrest

  3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min)

  4: Patients with confirmed or suspected pregnancy

  5: Patients with Intracranial hemorrhage

  6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases

  7: Patients who are unwilling to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Levosimendan group

Experimental group

Description:

The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.

Treatment:

Drug: Levosimendan Injection

Placebo group

Placebo Comparator group

Description:

The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.

Treatment:

Drug: physiological saline