RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

NCT05956431 | Unknown Phase 4

• 1 other identifier: M2023327
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Arrest

Keywords

cardiac arrest; Levosimendan Injection; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Survival rate

  after 1 week of resuscitation

• Echocardiography

  On the first week after resuscitation

• Neuron-Specific Enolase (NSE)

  On the first week after resuscitation

• Gray-to-White Matter Ratio (GWR)

  On the first week after resuscitation

• Serum creatinine

  On the first week after resuscitation

Study Arms (2)

Levosimendan group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Levosimendan Injection 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.

Also known as: Intervention Group

Levosimendan group

physiological saline 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.

Also known as: Placebo Group

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age\>18 years old
• : 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
• : Patients with witnessed cardiac arrest
• : ROSC lasts for less than 60 minutes
• : Low cardiac output syndrome after ROSC (LVEF\<40%)
• : Still in a coma after ROSC, Glasgow score\<8 points
• : Complete enrollment within 180 minutes after ROSC

You may not qualify if:

• : Patients receiving extracorporeal Cardiopulmonary resuscitation
• : Patients with severe neurological deficits prior to cardiac arrest
• : Patients with severe renal dysfunction (creatinine clearance rate\<30ml/min)
• : Patients with confirmed or suspected pregnancy
• : Patients with Intracranial hemorrhage
• : Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases
• : Patients who are unwilling to participate in the study

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Qilu Hospital of Shandong University: collaborator

MeSH Terms

Conditions

Heart Arrest

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ma Qingbian, doctor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Du Lanfang, doctor

CONTACT

13810363269; angelslovedudu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 21, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When the study is fully completed, it can be shared.
• Access Criteria: open access