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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

TypeNameDescription
DRUGInfliximabThe 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.
DRUGSodium 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.