RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Phase 4

Not yet recruiting

• Conditions: Heart Arrest
• Interventions: Drug: physiological saline; Drug: Levosimendan Injection

• Registration Number: NCT05956431
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Study Start: 2023-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	physiological saline	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.
Levosimendan group	Levosimendan Injection	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.

Primary Outcome Measures

Name	Time	Method
Cerebral Performance Category (CPC)	On the 30th day after cardiac arrest	The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.

Secondary Outcome Measures

Name	Time	Method
Survival rate	after 1 week of resuscitation	Survival rate after 1 week of resuscitation was counted
Echocardiography	On the first week after resuscitation	After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process
Neuron-Specific Enolase (NSE)	On the first week after resuscitation	After enrollment, NSE was collected according to the specified time points in this study process
Gray-to-White Matter Ratio (GWR)	On the first week after resuscitation	After enrollment, head CT GWR were collected according to the specified time points in this study process
Serum creatinine	On the first week after resuscitation	After enrollment, serum creatinine indicators representing renal function were collected according to the specified time