Heart Arrest
Conditions
Keywords
cardiac arrest, Levosimendan Injection, prognosis
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.
Interventions
DRUGLevosimendan 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.
DRUGphysiological 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.
Sponsors
Qilu Hospital of Shandong University
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | after 1 week of resuscitation | Survival rate after 1 week of resuscitation was counted |
| Echocardiography | On the first week after resuscitation | After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process |
| 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 |
| 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 |
| Serum creatinine | On the first week after resuscitation | After enrollment, serum creatinine indicators representing renal function were collected according to the specified time |
Contacts
Primary ContactDu Lanfang, doctor
Outcome results
None listed