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

NCT07176754 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER
  • Peking University People's Hospital

    collaborator OTHER
  • Peking University Shenzhen Hospital

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • Jiangsu Provincial People's Hospital

    collaborator OTHER
  • Hunan Provincial People's Hospital

    collaborator OTHER
  • Sichuan Provincial People's Hospital

    collaborator OTHER
  • People's Hospital of Guangxi Zhuang Autonomous Region

    collaborator OTHER
  • People's Hospital of Xinjiang Uygur Autonomous Region

    collaborator OTHER
  • Renmin Hospital of Wuhan University

    collaborator OTHER
  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-07-31
Completion
2028-10-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176754 on ClinicalTrials.gov