TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.
NCT07176754 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2025-09-16
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.
Conditions
- Cardiac Arrest (CA)
- Post Cardiac Arrest Syndrome
Interventions
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
Peking University First Hospital
collaborator OTHER -
Peking University People's Hospital
collaborator OTHER -
Peking University Shenzhen Hospital
collaborator OTHER -
Qilu Hospital of Shandong University
collaborator OTHER -
Jiangsu Provincial People's Hospital
collaborator OTHER -
Hunan Provincial People's Hospital
collaborator OTHER -
Sichuan Provincial People's Hospital
collaborator OTHER -
People's Hospital of Guangxi Zhuang Autonomous Region
collaborator OTHER -
People's Hospital of Xinjiang Uygur Autonomous Region
collaborator OTHER -
Renmin Hospital of Wuhan University
collaborator OTHER -
Peking University Third Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2028-07-31
- Completion
- 2028-10-31
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