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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
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.
Peking University Third Hospital
Beijing, China
30-day survival rate
All-cause survival rate of patients on day 30 after randomization.
Time frame: 30 days after randomization.
Rate of good neurological function assessed by Modified Rankin scale neurologic function scores
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
Rate of good neurological function assessed by cerebral performance category scores
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: 30 days, 3 months, and 6 months after randomization
prolong follow-up survival rate
survival rate
Time frame: 3 months and 6 months after randomization
systematic scoring
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
Serum concentrations of systemic inflammatory response markers
CRP, WBC, IL-1 β, IL-6, TNF - α, etc at 24h, 48h, 72h and 1 week after randomization
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Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization
Serum concentrations of myocardial injury markers
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
Serum concentrations of neuronal specific enolase
NSE at 24h, 48h, 72h and 1 week after randomization
Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization