RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05956431
• Collaborator: Qilu Hospital of Shandong University (Other)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest	Drug: Levosimendan Injection; Drug: physiological saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cerebral Performance Category (CPC) [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.

Secondary Outcome Measures

1. Survival rate [after 1 week of resuscitation]

   Survival rate after 1 week of resuscitation was counted

2. Echocardiography [On the first week after resuscitation]

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

3. Neuron-Specific Enolase (NSE) [On the first week after resuscitation]

   After enrollment, NSE was collected according to the specified time points in this study process

4. Gray-to-White Matter Ratio (GWR) [On the first week after resuscitation]

   After enrollment, head CT GWR were collected according to the specified time points in this study process

5. Serum creatinine [On the first week after resuscitation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Third Hospital
• Qilu Hospital of Shandong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Du Lanfang, associate professor, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05956431
• Other Study ID Numbers: M2023327
• First Posted: Jul 21, 2023
• Last Update Posted: Jul 21, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Du Lanfang, associate professor, Peking University Third Hospital: cardiac arrest; Levosimendan Injection; prognosis
• Additional relevant MeSH terms: Heart Arrest; Simendan

Study Results

No Results Posted as of Jul 21, 2023