RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Peking University Third Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Heart Arrest

Interventions

Levosimendan InjectionDRUG

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.

physiological salineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: On the 30th day after cardiac arrest

Secondary Outcomes

Survival rate

Survival rate after 1 week of resuscitation was counted

Time frame: after 1 week of resuscitation

Echocardiography

After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process

Time frame: 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

Time frame: 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

Time frame: On the first week after resuscitation

Serum creatinine

After enrollment, serum creatinine indicators representing renal function were collected according to the specified time

Time frame: On the first week after resuscitation

Central Contacts

Du Lanfang, doctor

CONTACT

13810363269 angelslovedudu@126.com

Data from ClinicalTrials.gov

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