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

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest (CA); Post Cardiac Arrest Syndrome
• Interventions: Drug: Infliximab; Drug: Sodium chloride injection USP, 0.9% (placebo)

• Registration Number: NCT07176754
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2028-07-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Infliximab	Patients in the intervention group received a TNF-α antagonist (infliximab) within 6 hours after return of spontaneous circulation(ROSC).
control group	Sodium chloride injection USP, 0.9% (placebo)	Patients in the control group received 250 mL of 0.9% sodium chloride injection as a placebo.

Primary Outcome Measures

Name	Time	Method
30-day survival rate	30 days after randomization.	All-cause survival rate of patients on day 30 after randomization.

Secondary Outcome Measures

Name	Time	Method
Rate of good neurological function assessed by Modified Rankin scale neurologic function scores and cerebral performance category scores	30 days, 3 months, and 6 months after randomization	Modified Rankin scale neurologic function scores and cerebral performance category(CPC) scores at 30 days, 3 months, and 6 months after randomization. Neurological function was assessed using the CPC and mRS scales, with CPC 1-2 and mRS 0-3 scores indicating a good neurological prognosis, and CPC 3-5 and mRS 4-6 scores indicating a poor neurological prognosis.
prolong follow-up survival rate	3 months and 6 months after randomization	survival rate
systematic scoring	24 hours (h), 48 hours, 72 hours and 1 week after randomization	SOFA score at 24h, 48h, 72h and 1 week after randomization