Trials / Not Yet Recruiting
Not Yet RecruitingNCT07176754
TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.
TNF-a Antagonists Attenuate the Systemic Inflammatory Response in Post-cardiac Arrest Syndrome: a Multi Centre, Double-blind, Randomised Controlled Clinical Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- Sponsor
- Peking University Third Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| 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. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2028-07-31
- Completion
- 2028-10-31
- First posted
- 2025-09-16
- Last updated
- 2025-09-16
Source: ClinicalTrials.gov record NCT07176754. Inclusion in this directory is not an endorsement.