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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
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Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.Further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.Moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. Surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. Moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague.
Therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance.
Multimodal neuromonitoring, integrating tools such as near-infrared spectroscopy (NIRS), transcranial Doppler, and continuous electroencephalography, may enable early detection of brain injury and guide targeted interventions.
Hypothesis: Multimodal neuromonitoring combined with a standard care management will increase the proportion of patients achieving survival with favorable neurological outcome (Cerebral Performance Category [CPC] 1-2) at 30 days compared with standard care without protocolized neuromonitoring.
Primary Objective: To test whether a multimodal neuromonitoring strategy improves 30-day survival with favorable neurological outcome (CPC 1-2) in adult patients with refractory cardiac arrest treated with ECPR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | Standard monitoring (including vital signs monitoring, blood gas analysis, and lactate levels) based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results). Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature between 32 and 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours. |
|
| Multimodal monitoring strategy | Experimental | Experimental group: In addition to standard treatment in the control group, a multimodal monitoring system of brain function is integrated: continuous rSO2 monitoring with at least once-daily TCD for cerebral blood flow velocity monitoring, ONSD ultrasound measurement, and EEG monitoring. Based on the cerebral oxygenation target-directed management strategies, intervention measures such as the ECMO blood flow, the dose of vasoactive drugs, mechanical ventilation parameters, target temperature management, sedation and analgesia plans, and antiepileptic drugs are dynamically adjusted to ultimately achieve the goal of brain oxygenation target value (rSO2) to 58%-68%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| if rSO2 < 58% | Other | Use Vasoactive drugs(MAP 65-95mmHg); Use Cardiotonic agents(CO 3.0-4.5L/min); Increase ECMO blood flow rate(Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O);ONSD<5.5mm); Antiepileptic therapy(EEG shows no seizures); Optimize sedation and analgesia; Target Temperature Management |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable neurological outcome (CPC scale 1-2) at 30 days | Cerebral Performance Category (CPC) score will be performed to evaluate the neurological status. A CPC score of 1 or 2 indicates a favorable neurological status. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to 30 days and 90 days; | Does multimodal neurological monitoring Strategy improve the survival rates of 30 days and 90 days after cardiac arrest | 30 days and 90 days |
| Favorable neurological outcome (CPC 1-2) at 90 days; |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianfei Ji, MD. PhD | Contact | 0086-531-82165072 | qlyyjxf@163.com | |
| Feng Xu, MD. PhD | Contact | 86-0531-82165675 | xufengsdu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuguo Chen, MD. PhD | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital | Not yet recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37296666 | Background | Khanduja S, Kim J, Kang JK, Feng CY, Vogelsong MA, Geocadin RG, Whitman G, Cho SM. Hypoxic-Ischemic Brain Injury in ECMO: Pathophysiology, Neuromonitoring, and Therapeutic Opportunities. Cells. 2023 Jun 5;12(11):1546. doi: 10.3390/cells12111546. | |
| 35883697 | Background | Tas J, Eleveld N, Borg M, Bos KDJ, Langermans AP, van Kuijk SMJ, van der Horst ICC, Elting JWJ, Aries MJH. Cerebral Autoregulation Assessment Using the Near Infrared Spectroscopy 'NIRS-Only' High Frequency Methodology in Critically Ill Patients: A Prospective Cross-Sectional Study. Cells. 2022 Jul 21;11(14):2254. doi: 10.3390/cells11142254. |
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| Second Affiliated Hospital of Zhengzhou University |
| OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Jiangsu Provincial People's Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Beijing Anzhen Hospital | OTHER |
| The Second Hospital University of South China | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Heze Municipal Hospital | OTHER |
| Shenzhen People's Hospital, The Second Medical College of Jinan University | OTHER |
| Liaocheng People's Hospital | OTHER |
| Jining First People's Hospital | OTHER |
| Weifang People's Hospital | OTHER |
| The First People's Hospital of Lianyungang | OTHER |
| Huai'an First People's Hospital | OTHER |
The control group: Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions). Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults. including regulating ECMO blood flow, the dose of vasoactive drugs , mechanical ventilation parameters, sedation and analgesia plans.
The experimental group：For patients with refractory cardiac arrest undergoing ECPR, continuous cerebral oxygenation monitoring was used. Guided by the target-directed management strategies targeting cerebral oxygenation, interventions were dynamically adjusted. These adjustments included modifying ECMO blood flow rates, titrating vasoactive drug dosages, optimizing mechanical ventilation parameters, administering osmotic dehydration therapy, using antiepileptic drugs, and implementing targeted temperature management.
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|
| if rSO2 58%-68% | Other | Optimize ECMO blood flow rate( Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O);ONSD<5.5mm); Optimize sedation and analgesia; Antiepileptic therapy(EEG shows no seizures); Target Temperature Management |
|
| rSO2>68% | Other | Antihypertensive therapy(MAP ≥65mmHg); Inhibiting myocardial contractility and controls ventricular rate(CO 2.5-3.0 L/min); Decrease ECMO blood flow rate(Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O); Antiepileptic therapy(EEG shows no seizures); Optimize sedation and analgesia; Target Temperature Management |
|
| Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results). | Other | Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature 32- 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours. |
|
| Standard monitoring based on ECPR | Other | Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature 32- 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours. |
|
Cerebral Performance Category (CPC) score will be performed to evaluate the neurological status. A CPC score of 1 or 2 indicates a favorable neurological status
| 90 days |
| Duration of mechanical ventilation | Is there a difference in the duration of mechanical ventilation between treatment groups | 1 year |
| Length of stay at the ICU | Is there a difference in length of stay at the ICU between the treatment groups | 1 year |
| Length of stay at the hospital | Is there a difference in length of stay at the hospital between the treatment groups | 1 year |
| Difference in NSE level between treatment groups | Is there a difference in nerve damage Markers such as NSE at ROSC 24h, 48h, 72h between the treatment groups | 3 days |
| ECMO-related complication rates such as hemorrhage, infarction, lower limb ischemic necrosis, etc. | Is there a difference in ECMO-related complication between the treatment groups | 1 year |
| ECMO duration | Is there a difference in the duration of ECMO between treatment groups | 1 year |
| Qilu hospital | Recruiting | Jinan | Shandong | 250012 | China |
|
| 39337852 | Background | Lim SL, Myint MZ, Woo KL, Chee EYH, Hong CS, Beqiri E, Smielewski P, Ong MEH, Sharma VK. Multi-Modal Assessment of Cerebral Hemodynamics in Resuscitated Out-of-Hospital Cardiac Arrest Patients: A Case-Series. Life (Basel). 2024 Aug 26;14(9):1067. doi: 10.3390/life14091067. |
| Background | Wei G, Huang G, Zhu C, Jiang W, Hu B: Application of extracorporeal cardiopulmonary resuscitation in emergency refractory cardiac arrest and analysis of prognostic factors. Journal of Practical Medicine 2024, 40(24):3446-3451. |
| 38108133 | Background | Perman SM, Elmer J, Maciel CB, Uzendu A, May T, Mumma BE, Bartos JA, Rodriguez AJ, Kurz MC, Panchal AR, Rittenberger JC; American Heart Association. 2023 American Heart Association Focused Update on Adult Advanced Cardiovascular Life Support: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2024 Jan 30;149(5):e254-e273. doi: 10.1161/CIR.0000000000001194. Epub 2023 Dec 18. |
| Background | Li X, Mai C: Goal-oriented precision brain resuscitation: current status and prospects. Chinese Journal of Emergency Medicine 2024, 33(1):1-5. |
| 36480063 | Background | Benghanem S, Pruvost-Robieux E, Bouchereau E, Gavaret M, Cariou A. Prognostication after cardiac arrest: how EEG and evoked potentials may improve the challenge. Ann Intensive Care. 2022 Dec 8;12(1):111. doi: 10.1186/s13613-022-01083-9. |
| 35471582 | Background | Sandroni C, Cronberg T, Hofmeijer J. EEG monitoring after cardiac arrest. Intensive Care Med. 2022 Oct;48(10):1439-1442. doi: 10.1007/s00134-022-06697-y. Epub 2022 Apr 26. No abstract available. |
| 30019201 | Background | Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17. |
| 35230559 | Background | Calviello LA, Cardim D, Czosnyka M, Preller J, Smielewski P, Siyal A, Damian MS. Feasibility of non-invasive neuromonitoring in general intensive care patients using a multi-parameter transcranial Doppler approach. J Clin Monit Comput. 2022 Dec;36(6):1805-1815. doi: 10.1007/s10877-022-00829-x. Epub 2022 Mar 1. |
| 31145934 | Background | Rafi S, Tadie JM, Gacouin A, Leurent G, Bedossa M, Le Tulzo Y, Maamar A. Doppler sonography of cerebral blood flow for early prognostication after out-of-hospital cardiac arrest: DOTAC study. Resuscitation. 2019 Aug;141:188-194. doi: 10.1016/j.resuscitation.2019.05.024. Epub 2019 May 27. |
| 31580841 | Background | Lau VI, Jaidka A, Wiskar K, Packer N, Tang JE, Koenig S, Millington SJ, Arntfield RT. Better With Ultrasound: Transcranial Doppler. Chest. 2020 Jan;157(1):142-150. doi: 10.1016/j.chest.2019.08.2204. Epub 2019 Sep 30. |
| 28044331 | Background | Green DW, Kunst G. Cerebral oximetry and its role in adult cardiac, non-cardiac surgery and resuscitation from cardiac arrest. Anaesthesia. 2017 Jan;72 Suppl 1:48-57. doi: 10.1111/anae.13740. |
| 26418554 | Background | Moerman A, De Hert S. Cerebral oximetry: the standard monitor of the future? Curr Opin Anaesthesiol. 2015 Dec;28(6):703-9. doi: 10.1097/ACO.0000000000000256. |
| 33765189 | Background | Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25. |
| 34133859 | Background | Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591. |
| 38934122 | Background | Perkins GD, Neumar R, Hsu CH, Hirsch KG, Aneman A, Becker LB, Couper K, Callaway CW, Hoedemaekers CWE, Lim SL, Meurer W, Olasveengen T, Sekhon MS, Skrifvars M, Soar J, Tsai MS, Vengamma B, Nolan JP; International Liaison Committee on Resuscitation. Improving Outcomes After Post-Cardiac Arrest Brain Injury: A Scientific Statement From the International Liaison Committee on Resuscitation. Circulation. 2024 Jun 27. doi: 10.1161/CIR.0000000000001219. Online ahead of print. |
| 33773833 | Background | Grasner JT, Herlitz J, Tjelmeland IBM, Wnent J, Masterson S, Lilja G, Bein B, Bottiger BW, Rosell-Ortiz F, Nolan JP, Bossaert L, Perkins GD. European Resuscitation Council Guidelines 2021: Epidemiology of cardiac arrest in Europe. Resuscitation. 2021 Apr;161:61-79. doi: 10.1016/j.resuscitation.2021.02.007. Epub 2021 Mar 24. |
| 36531179 | Result | Tas J, Czosnyka M, van der Horst ICC, Park S, van Heugten C, Sekhon M, Robba C, Menon DK, Zeiler FA, Aries MJH. Cerebral multimodality monitoring in adult neurocritical care patients with acute brain injury: A narrative review. Front Physiol. 2022 Dec 1;13:1071161. doi: 10.3389/fphys.2022.1071161. eCollection 2022. |
| 35191923 | Result | Belohlavek J, Smalcova J, Rob D, Franek O, Smid O, Pokorna M, Horak J, Mrazek V, Kovarnik T, Zemanek D, Kral A, Havranek S, Kavalkova P, Kompelentova L, Tomkova H, Mejstrik A, Valasek J, Peran D, Pekara J, Rulisek J, Balik M, Huptych M, Jarkovsky J, Malik J, Valerianova A, Mlejnsky F, Kolouch P, Havrankova P, Romportl D, Komarek A, Linhart A; Prague OHCA Study Group. Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2022 Feb 22;327(8):737-747. doi: 10.1001/jama.2022.1025. |
| 29883008 | Result | Ertl M, Weber S, Hammel G, Schroeder C, Krogias C. Transorbital Sonography for Early Prognostication of Hypoxic-Ischemic Encephalopathy After Cardiac Arrest. J Neuroimaging. 2018 Sep;28(5):542-548. doi: 10.1111/jon.12528. Epub 2018 Jun 8. |
| 34865837 | Result | Ong CS, Etchill E, Dong J, Shou BL, Shelley L, Giuliano K, Al-Kawaz M, Ritzl EK, Geocadin RG, Kim BS, Bush EL, Choi CW, Whitman GJR, Cho SM. Neuromonitoring detects brain injury in patients receiving extracorporeal membrane oxygenation support. J Thorac Cardiovasc Surg. 2023 Jun;165(6):2104-2110.e1. doi: 10.1016/j.jtcvs.2021.09.063. Epub 2021 Oct 30. |
| 36720132 | Result | Suverein MM, Delnoij TSR, Lorusso R, Brandon Bravo Bruinsma GJ, Otterspoor L, Elzo Kraemer CV, Vlaar APJ, van der Heijden JJ, Scholten E, den Uil C, Jansen T, van den Bogaard B, Kuijpers M, Lam KY, Montero Cabezas JM, Driessen AHG, Rittersma SZH, Heijnen BG, Dos Reis Miranda D, Bleeker G, de Metz J, Hermanides RS, Lopez Matta J, Eberl S, Donker DW, van Thiel RJ, Akin S, van Meer O, Henriques J, Bokhoven KC, Mandigers L, Bunge JJH, Bol ME, Winkens B, Essers B, Weerwind PW, Maessen JG, van de Poll MCG. Early Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest. N Engl J Med. 2023 Jan 26;388(4):299-309. doi: 10.1056/NEJMoa2204511. |
| Result | Chen Y, Xu F. Report on Cardiac Arrest and Cardiopulmonary Resuscitation in China (2022 Edition) [M]. Beijing: People's Medical Publishing House, 2023. |
| 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. |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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