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Cardiac Arrest (CA)NCT07176754

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

A study testing Infliximab in people with Cardiac Arrest (CA) and Post Cardiac Arrest Syndrome, run by Peking University Third Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
1 siteChina
Study dates
1 Oct 2025to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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);
Show all 17Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing

Other trials in China

About this study

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

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.

Being tested
Infliximab, Sodium chloride injection USP, 0.9% (placebo)
Keywords
cardiac arrest, post cardiac arrest syndrome, TNF-α antagonism
Medical subject headings
Heart Arrest, Post-Cardiac Arrest Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    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.

Study groups in NCT07176754
Study groupRoleWhat they receive
intervention groupExperimentalPatients in the intervention group received a TNF-α antagonist (infliximab) within 6 hours after return of spontaneous circulation(ROSC).
Receives: Drug: Infliximab
control groupPlacebo comparatorThe control group patients received 0.9% sodium chloride injection within 6 hours after restoration of spontaneous circulation (ROSC).
Receives: Drug: Sodium chloride injection USP, 0.9% (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day survival rate

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

    Measured: 30 days after randomization.

Secondary outcomes (7)

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

    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.

    Measured: 30 days, 3 months, and 6 months after randomization

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

    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.

    Measured: 30 days, 3 months, and 6 months after randomization

  3. prolong follow-up survival rate

    survival rate

    Measured: 3 months and 6 months after randomization

  4. systematic scoring

    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.

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

  5. Serum concentrations of systemic inflammatory response markers

    CRP, WBC, IL-1 β, IL-6, TNF - α, etc at 24h, 48h, 72h and 1 week after randomization

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

  6. Serum concentrations of myocardial injury markers

    TNI,BNP,MYO,CKMB,etc at 24h, 48h, 72h and 1 week after randomization

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

  7. Serum concentrations of neuronal specific enolase

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Oct 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176754
Sponsor's protocol ID
IRB00006761-M20250549
Status last verified
Jun 2025
First submitted
4 Jul 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhou Y, Fan R, Botchway BOA, Zhang Y, Liu X. Infliximab Can Improve Traumatic Brain Injury by Suppressing the Tumor Necrosis Factor Alpha Pathway. Mol Neurobiol. 2021 Jun;58(6):2803-2811. doi: 10.1007/s12035-021-02293-1. Epub 2021 Jan 27.

    PubMed 33501626

  • Chen AQ, Fang Z, Chen XL, Yang S, Zhou YF, Mao L, Xia YP, Jin HJ, Li YN, You MF, Wang XX, Lei H, He QW, Hu B. Microglia-derived TNF-alpha mediates endothelial necroptosis aggravating blood brain-barrier disruption after ischemic stroke. Cell Death Dis. 2019 Jun 20;10(7):487. doi: 10.1038/s41419-019-1716-9.

    PubMed 31221990

  • Yin Z, Raj D, Saiepour N, Van Dam D, Brouwer N, Holtman IR, Eggen BJL, Moller T, Tamm JA, Abdourahman A, Hol EM, Kamphuis W, Bayer TA, De Deyn PP, Boddeke E. Immune hyperreactivity of Abeta plaque-associated microglia in Alzheimer's disease. Neurobiol Aging. 2017 Jul;55:115-122. doi: 10.1016/j.neurobiolaging.2017.03.021. Epub 2017 Mar 27.

    PubMed 28434692

  • Cain BS, Meldrum DR, Dinarello CA, Meng X, Joo KS, Banerjee A, Harken AH. Tumor necrosis factor-alpha and interleukin-1beta synergistically depress human myocardial function. Crit Care Med. 1999 Jul;27(7):1309-18. doi: 10.1097/00003246-199907000-00018.

    PubMed 10446825

  • Stellwagen D, Beattie EC, Seo JY, Malenka RC. Differential regulation of AMPA receptor and GABA receptor trafficking by tumor necrosis factor-alpha. J Neurosci. 2005 Mar 23;25(12):3219-28. doi: 10.1523/JNEUROSCI.4486-04.2005.

    PubMed 15788779

  • Robertson J, Beaulieu JM, Doroudchi MM, Durham HD, Julien JP, Mushynski WE. Apoptotic death of neurons exhibiting peripherin aggregates is mediated by the proinflammatory cytokine tumor necrosis factor-alpha. J Cell Biol. 2001 Oct 15;155(2):217-26. doi: 10.1083/jcb.200107058. Epub 2001 Oct 15.

    PubMed 11604419

  • Lu D, Goussev A, Chen J, Pannu P, Li Y, Mahmood A, Chopp M. Atorvastatin reduces neurological deficit and increases synaptogenesis, angiogenesis, and neuronal survival in rats subjected to traumatic brain injury. J Neurotrauma. 2004 Jan;21(1):21-32. doi: 10.1089/089771504772695913.

    PubMed 14987462

  • Aloisi F, Care A, Borsellino G, Gallo P, Rosa S, Bassani A, Cabibbo A, Testa U, Levi G, Peschle C. Production of hemolymphopoietic cytokines (IL-6, IL-8, colony-stimulating factors) by normal human astrocytes in response to IL-1 beta and tumor necrosis factor-alpha. J Immunol. 1992 Oct 1;149(7):2358-66.

    PubMed 1382099

  • Annborn M, Dankiewicz J, Erlinge D, Hertel S, Rundgren M, Smith JG, Struck J, Friberg H. Procalcitonin after cardiac arrest - an indicator of severity of illness, ischemia-reperfusion injury and outcome. Resuscitation. 2013 Jun;84(6):782-7. doi: 10.1016/j.resuscitation.2013.01.004. Epub 2013 Jan 8.

    PubMed 23313427

  • Tae HJ, Kang IJ, Lee TK, Cho JH, Lee JC, Shin MC, Kim YS, Cho JH, Kim JD, Ahn JH, Park JH, Kim IS, Lee HA, Kim YH, Won MH, Lee YJ. Neuronal injury and tumor necrosis factor-alpha immunoreactivity in the rat hippocampus in the early period of asphyxia-induced cardiac arrest under normothermia. Neural Regen Res. 2017 Dec;12(12):2007-2013. doi: 10.4103/1673-5374.221157.

    PubMed 29323039

  • Nolan JP, Neumar RW, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Hoek TV. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A Scientific Statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; the Council on Stroke. Resuscitation. 2008 Dec;79(3):350-79. doi: 10.1016/j.resuscitation.2008.09.017. Epub 2008 Oct 28.

    PubMed 18963350

  • Mentzelopoulos SD, Zakynthinos SG. Post-cardiac arrest syndrome: pathological processes, biomarkers and vasopressor support, and potential therapeutic targets. Resuscitation. 2017 Dec;121:A12-A14. doi: 10.1016/j.resuscitation.2017.10.013. Epub 2017 Oct 18. No abstract available.

    PubMed 29055751

  • Zheng J, Lv C, Zheng W, Zhang G, Tan H, Ma Y, Zhu Y, Li C, Han X, Yan S, Pan C, Zhang J, Hou Y, Wang C, Bian Y, Liu R, Cheng K, Ma J, Zheng Z, Song R, Wang M, Gu J, McNally B, Ong MEH, Chen Y, Xu F; BASIC-OHCA Coordinators and Investigators. Incidence, process of care, and outcomes of out-of-hospital cardiac arrest in China: a prospective study of the BASIC-OHCA registry. Lancet Public Health. 2023 Dec;8(12):e923-e932. doi: 10.1016/S2468-2667(23)00173-1. Epub 2023 Sep 16.

    PubMed 37722403

Questions about this trial

What is this clinical trial studying?

A study testing Infliximab in people with Cardiac Arrest (CA) and Post Cardiac Arrest Syndrome, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day survival rate (time frame: 30 days after randomization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176754, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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