Peking University Third Hospital
Beijing, China
NCT Number: NCT07176754
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo, administered via intravenous infusion over 2 hours.
Time frame: 30 days after randomization.
All-cause survival rate of patients on day 30 after randomization.
Time frame: 30 days, 3 months, and 6 months after randomization
Modified Rankin scale neurologic function scores at 30 days, 3 months, and 6 months after randomization. Neurological function was assessed using the mRS scales, with mRS 0-3 scores indicating a good neurological prognosis, and mRS 4-6 scores indicating a poor neurological prognosis.
Time frame: 30 days, 3 months, and 6 months after randomization
Cerebral performance category(CPC) scores at 30 days, 3 months, and 6 months after randomization. Neurological function was assessed using the CPC, with CPC 1-2 indicating a good neurological prognosis, and CPC 3-5 scores indicating a poor neurological prognosis.
Time frame: 3 months and 6 months after randomization
survival rate
Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization
The Sequential Organ Failure Assessment (SOFA) Score-ranging from 0 (minimum) to 24 (maximum), with higher scores indicating more severe organ dysfunction and worse clinical outcomes-was measured at 24 hours, 48 hours, 72 hours, and 1 week after randomization.
Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization
CRP, WBC, IL-1 β, IL-6, TNF - α, etc at 24h, 48h, 72h and 1 week after randomization
Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization
TNI,BNP,MYO,CKMB,etc at 24h, 48h, 72h and 1 week after randomization
Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization
NSE at 24h, 48h, 72h and 1 week after randomization
Peking University Third Hospital
Other
TNF-a Antagonists Attenuate the Systemic Inflammatory Response in Post-cardiac Arrest Syndrome: a Multi Centre, Double-blind, Randomised Controlled Clinical Study
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