RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Heart Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956431
• Other study ID #: M2023327
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: Du Lanfang, doctor
• Phone: 13810363269
• Email: angelslovedudu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival rate	Survival rate after 1 week of resuscitation was counted	after 1 week of resuscitation
Secondary	Echocardiography	After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process	On the first week after resuscitation
Secondary	Neuron-Specific Enolase (NSE)	After enrollment, NSE was collected according to the specified time points in this study process	On the first week after resuscitation
Secondary	Gray-to-White Matter Ratio (GWR)	After enrollment, head CT GWR were collected according to the specified time points in this study process	On the first week after resuscitation
Secondary	Serum creatinine	After enrollment, serum creatinine indicators representing renal function were collected according to the specified time	On the first week after resuscitation