A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
Overview
- Phase
- Phase 4
- Intervention
- Levosimendan Injection
- Conditions
- Heart Arrest
- Sponsor
- Peking University Third Hospital
- Enrollment
- 60
- Primary Endpoint
- Cerebral Performance Category (CPC)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Du Lanfang
associate professor
Peking University Third Hospital
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Levosimendan Injection
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.
Intervention: physiological saline
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)