Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Peking University Shenzhen Hospital | OTHER |
| Qilu Hospital of Shandong University |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Patients in the intervention group received a TNF-α antagonist (infliximab) within 6 hours after return of spontaneous circulation(ROSC). |
|
| control group | Placebo Comparator | The control group patients received 0.9% sodium chloride injection within 6 hours after restoration of spontaneous circulation (ROSC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day survival rate | All-cause survival rate of patients on day 30 after randomization. | 30 days after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days, 3 months, and 6 months after randomization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33501626 | Result | 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. | |
| 31221990 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D000080942 | Post-Cardiac Arrest Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
| OTHER |
| Jiangsu Provincial People's Hospital | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| Zhongnan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | 30 days, 3 months, and 6 months after randomization |
| prolong follow-up survival rate | survival rate | 3 months and 6 months after randomization |
| 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. | 24 hours (h), 48 hours, 72 hours and 1 week after randomization |
| 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 | 24 hours (h), 48 hours, 72 hours and 1 week after randomization |
| Serum concentrations of myocardial injury markers | TNI,BNP,MYO,CKMB,etc at 24h, 48h, 72h and 1 week after randomization | 24 hours (h), 48 hours, 72 hours and 1 week after randomization |
| Serum concentrations of neuronal specific enolase | NSE at 24h, 48h, 72h and 1 week after randomization | 24 hours (h), 48 hours, 72 hours and 1 week after randomization |
| 28434692 | Result | 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. |
| 10446825 | Result | 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. |
| 15788779 | Result | 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. |
| 11604419 | Result | 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. |
| 14987462 | Result | 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. |
| 1382099 | Result | 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. |
| 23313427 | Result | 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. |
| 29323039 | Result | 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. |
| 18963350 | Result | 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. |
| 29055751 | Result | 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. |
| 37722403 | Result | 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. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |