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Active, not recruiting Not applicable

TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.

NCT07176754 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2026-06-10

Condition(s) studied

Cardiac Arrest (CA)Post Cardiac Arrest Syndrome

Investigational drug(s) / intervention(s)

Infliximab →Sodium chloride injection USP, 0.9% (placebo)

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.

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing China
Official registry record

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.

View NCT07176754 on ClinicalTrials.gov ↗ ← All trials in China