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Active, Not Recruiting

NCT Number: NCT07176754

TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years;
  • Patients with suspected cardiogenic cardiac arrest;
  • Patients with comatose state after ROSC (Glasgow Coma Scale [GCS] score <9);
  • Patients with Return of spontaneous circulation (ROSC) sustained for >20 minutes;

Exclusion criteria

  • Cardiac arrest due to trauma;
  • Suspected or confirmed hemorrhagic or ischemic stroke;
  • Pregnancy;
  • Cardiac arrest without witnessed collapse;
  • Admission body temperature <30°C;
  • Persistent cardiogenic shock (defined as systolic blood pressure below 90mmHg during the screening period despite adequate fluid resuscitation, vasopressors, and positive inotropic drug support);
  • Time from ROSC to randomization exceeding 4 hours;
  • Left ventricular ejection fraction (LVEF) <35% after ROSC;
  • Known allergy to TNF - α antagonist components
  • Known tuberculosis or other active infection;
  • Diagnosed advanced malignant tumors with an estimated survival period of less than 6 months;
  • Pre-existing severe neurological dysfunction before cardiac arrest (e.g., Cerebral Performance Category [CPC] 3-4);
  • End stage renal disease relies on dialysis;
  • Severe chronic obstructive pulmonary disease (COPD) and other diseases require long-term home oxygen therapy;
  • Being in a state of severe immune suppression (such as long-term use of immunosuppressants after autoimmune diseases or organ transplantation, or patients with severe immunodeficiency diseases);
  • History of liver cirrhosis;
  • History of chronic heart failure, heart function III-IV (NYHA)

Treatment and study plan

Infliximab

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.

Sodium chloride injection USP, 0.9% (placebo)

Drug

Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo, administered via intravenous infusion over 2 hours.

Primary outcomes

  1. 30-day survival rate

    Time frame: 30 days after randomization.

    All-cause survival rate of patients on day 30 after randomization.

Secondary outcomes

  1. Rate of good neurological function assessed by Modified Rankin scale neurologic function scores

    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.

  2. Rate of good neurological function assessed by cerebral performance category scores

    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.

  3. prolong follow-up survival rate

    Time frame: 3 months and 6 months after randomization

    survival rate

  4. systematic scoring

    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.

  5. Serum concentrations of systemic inflammatory response markers

    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

  6. Serum concentrations of myocardial injury markers

    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

  7. Serum concentrations of neuronal specific enolase

    Time frame: 24 hours (h), 48 hours, 72 hours and 1 week after randomization

    NSE at 24h, 48h, 72h and 1 week after randomization

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Hunan Provincial People's Hospital
  • Jiangsu Provincial People's Hospital
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking University Shenzhen Hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Qilu Hospital of Shandong University
  • Sichuan Provincial People's Hospital
  • Zhongnan Hospital

Registry information

Official study title

TNF-a Antagonists Attenuate the Systemic Inflammatory Response in Post-cardiac Arrest Syndrome: a Multi Centre, Double-blind, Randomised Controlled Clinical Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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