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

NCT ID: NCT07176754

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-10-31

Brief 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

Cardiac Arrest (CA); Post Cardiac Arrest Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

Patients in the intervention group received a TNF-α antagonist (infliximab) within 6 hours after return of spontaneous circulation(ROSC).

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: 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.

control group

Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo.

Group Type: PLACEBO_COMPARATOR

Sodium chloride injection USP, 0.9% (placebo)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged ≥18 years;

2. Patients with suspected cardiogenic cardiac arrest;

3. Patients with comatose state after ROSC (Glasgow Coma Scale [GCS] score <9);

4. Patients with Return of spontaneous circulation (ROSC) sustained for >20 minutes;

Exclusion Criteria

1. Cardiac arrest due to trauma;

2. Suspected or confirmed hemorrhagic or ischemic stroke;

3. Pregnancy;

4. Cardiac arrest without witnessed collapse;

5. Admission body temperature <30°C;

6. Persistent cardiogenic shock (defined as systolic blood pressure <90 mmHg despite aggressive intervention during screening);

7. Any underlying disease with an expected survival of <180 days;

8. Pre-existing severe neurological dysfunction before cardiac arrest (e.g., Cerebral Performance Category [CPC] 3-4);

9. Time from ROSC to randomization exceeding 4 hours;

10. Left ventricular ejection fraction (LVEF) <35% after ROSC;

11. Known hypersensitivity to TNF-α antagonist components;

12. Known tuberculosis or other active infections;

13. Known poor prognosis (as determined by the investigator);

14. History of liver cirrhosis;

15. History of chronic heart failure with NYHA functional class III-IV.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Hunan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role: collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qingbian Ma

Role: CONTACT

maqingbian@126.com

15611908229

MQingbian

Role: CONTACT

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Other Identifiers

IRB00006761-M20250549

Identifier Type: -

Identifier Source: org_study_id