drugset / Trial / NCT07176754
TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.
Active not recruiting
208 enrolled
Peking University Third Hospital
Hunan Provincial People's Hospital · collabJiangsu Provincial People's Hospital · collabPeking University First Hospital · collabPeking University People's Hospital · collabPeking University Shenzhen Hospital · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabPeople's Hospital of Xinjiang Uygur Autonomous Region · collabQilu Hospital of Shandong University · collabSichuan Provincial People's Hospital · collabZhongnan Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2025-10-01
- Primary completion
- 2028-07-31
- Completion
- 2028-10-31
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |