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Clinical Trials in China / NCT07176754
Active, not recruiting Not applicable

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

NCT07176754 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
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)

InfliximabSodium 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)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing China

On this site

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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