RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest

Conditions
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Heart Arrest

Intervention / Treatment
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* Drug: Levosimendan Injection
* Drug: physiological saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levosimendan group<br>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. | Drug: Levosimendan Injection<br>* 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.<br>* Other names: Intervention Group;|
| Placebo Comparator: Placebo group<br>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. | Drug: physiological saline<br>* 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.<br>* Other names: Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Performance Category (CPC) | 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. | On the 30th day after cardiac arrest | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, Levosimendan Injection, prognosis