RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Heart Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Levosimendan group

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.

Group Type EXPERIMENTAL

Levosimendan Injection

Intervention Type DRUG

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.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

physiological saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Intervention Group Placebo Group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No