RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

July 13, 2023 updated by: Du Lanfang, Peking University Third Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Intervention Group
Placebo Comparator: 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.
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.
Other Names:
  • Placebo Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: after 1 week of resuscitation
Survival rate after 1 week of resuscitation was counted
after 1 week of resuscitation
Echocardiography
Time Frame: On the first week after resuscitation
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)
Time Frame: On the first week after resuscitation
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)
Time Frame: On the first week after resuscitation
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
Time Frame: On the first week after resuscitation
After enrollment, serum creatinine indicators representing renal function were collected according to the specified time
On the first week after resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Qilu Hospital of Shandong University

Investigators

  • Study Chair: Ma Qingbian, doctor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2023327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research results will be shared.

IPD Sharing Time Frame

When the study is fully completed, it can be shared.

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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