Infliximab: 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.
Sodium chloride injection USP, 0.9% (placebo): Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo, administered via intravenous infusion over 2 hours.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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)
Primary outcome measure(s)
30-day survival rate — 30 days after randomization. All-cause survival rate of patients on day 30 after randomization.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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