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

Peking University

Status: Not yet enrolling

Conditions: Cardiac Arrest (CA); Post Cardiac Arrest Syndrome

Treatments: Drug: Infliximab; Drug: Sodium chloride injection USP, 0.9% (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07176754

IRB00006761-M20250549

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

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

Treatment:

Drug: Infliximab

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium chloride injection USP, 0.9% (placebo)