Cardiac Arrest (CA), Post Cardiac Arrest Syndrome
Conditions
Keywords
cardiac arrest, post cardiac arrest syndrome, TNF-α antagonism
Brief summary
The investigators assessed the effect of TNF-α antagonism within 6 hours of return of spontaneous circulation on 30-day mortality in patients who remained comatose after cardiopulmonary resuscitation (CPR) following cardiac arrest . In addition, the investigators explored the role of this treatment in modulating the systemic inflammatory response and its potential impact on 90- and 180-day morbidity and mortality and neurological outcomes.
Interventions
DRUGInfliximab
The TNF-α antagonist (infliximab) used by the experimenter was manufactured by Hisun Biopharmaceuticals Ltd. under the trade name "anbaite".The dosage was administered at 5 mg/kg, dissolved in 250 mL of 0.9% sodium chloride injection, and delivered via intravenous infusion over 2 hours.
Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo, administered via intravenous infusion over 2 hours.
Sponsors
Peking University Third Hospital
Peking University First Hospital
Peking University People's Hospital
Peking University Shenzhen Hospital
Qilu Hospital of Shandong University
Jiangsu Provincial People's Hospital
Hunan Provincial People's Hospital
Sichuan Provincial People's Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
People's Hospital of Xinjiang Uygur Autonomous Region
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years; 2. Patients with suspected cardiogenic cardiac arrest; 3. Patients with comatose state after ROSC (Glasgow Coma Scale \[GCS\] score \<9); 4. Patients with Return of spontaneous circulation (ROSC) sustained for \>20 minutes;
Exclusion criteria
1. Cardiac arrest due to trauma; 2. Suspected or confirmed hemorrhagic or ischemic stroke; 3. Pregnancy; 4. Cardiac arrest without witnessed collapse; 5. Admission body temperature \<30°C; 6. Persistent cardiogenic shock (defined as systolic blood pressure below 90mmHg during the screening period despite adequate fluid resuscitation, vasopressors, and positive inotropic drug support); 7. Time from ROSC to randomization exceeding 4 hours; 8. Left ventricular ejection fraction (LVEF) \<35% after ROSC; 9. Known allergy to TNF - α antagonist components 10. Known tuberculosis or other active infection; 11. Diagnosed advanced malignant tumors with an estimated survival period of less than 6 months; 12. Pre-existing severe neurological dysfunction before cardiac arrest (e.g., Cerebral Performance Category \[CPC\] 3-4); 13. End stage renal disease relies on dialysis; 14. Severe chronic obstructive pulmonary disease (COPD) and other diseases require long-term home oxygen therapy; 15. Being in a state of severe immune suppression (such as long-term use of immunosuppressants after autoimmune diseases or organ transplantation, or patients with severe immunodeficiency diseases)； 16. History of liver cirrhosis; 17. History of chronic heart failure, heart function III-IV (NYHA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day survival rate | 30 days after randomization. | All-cause survival rate of patients on day 30 after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of good neurological function assessed by Modified Rankin scale neurologic function scores | 30 days, 3 months, and 6 months after randomization | Modified Rankin scale neurologic function scores at 30 days, 3 months, and 6 months after randomization. Neurological function was assessed using the mRS scales, with mRS 0-3 scores indicating a good neurological prognosis, and mRS 4-6 scores indicating a poor neurological prognosis. |
| Rate of good neurological function assessed by cerebral performance category scores | 30 days, 3 months, and 6 months after randomization | Cerebral performance category(CPC) scores at 30 days, 3 months, and 6 months after randomization. Neurological function was assessed using the CPC, with CPC 1-2 indicating a good neurological prognosis, and CPC 3-5 scores indicating a poor neurological prognosis. |
| prolong follow-up survival rate | 3 months and 6 months after randomization | survival rate |
| systematic scoring | 24 hours (h), 48 hours, 72 hours and 1 week after randomization | The Sequential Organ Failure Assessment (SOFA) Score-ranging from 0 (minimum) to 24 (maximum), with higher scores indicating more severe organ dysfunction and worse clinical outcomes-was measured at 24 hours, 48 hours, 72 hours, and 1 week after randomization. |
| Serum concentrations of systemic inflammatory response markers | 24 hours (h), 48 hours, 72 hours and 1 week after randomization | CRP, WBC, IL-1 β, IL-6, TNF - α, etc at 24h, 48h, 72h and 1 week after randomization |
| Serum concentrations of myocardial injury markers | 24 hours (h), 48 hours, 72 hours and 1 week after randomization | TNI,BNP,MYO,CKMB,etc at 24h, 48h, 72h and 1 week after randomization |
| Serum concentrations of neuronal specific enolase | 24 hours (h), 48 hours, 72 hours and 1 week after randomization | NSE at 24h, 48h, 72h and 1 week after randomization |
Countries
China
Outcome results
None listed