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.
18-75 years old
Witnessed in-hospital or out-of-hospital cardiac arrest
Patients who did not achieve return of spontaneous circulation (ROSC) after 15 minutes of conventional cardiopulmonary resuscitation (CPR), or whose ROSC cannot be maintained, and who received ECPR
Time from cardiac arrest to initiation of CPR < 10 minutes
Aortic dissection
Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation
Pregnancy
Severe trauma
Sequential
if rSO2 < 58%
Other interventionUse 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
if rSO2 58%-68%
Other interventionOptimize 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 interventionAntihypertensive 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 interventionClinical 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 interventionClinical 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.
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.
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
Favorable neurological outcome (CPC 1-2) at 90 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
Duration of mechanical ventilation
Is there a difference in the duration of mechanical ventilation between treatment groups
Length of stay at the ICU
Is there a difference in length of stay at the ICU between the treatment groups
Click on the lead sponsor to view all of their trials.
Qilu Hospital of Shandong University
Lead sponsor
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Second Affiliated Hospital of Zhengzhou University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Hunan Provincial People's Hospital
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Beijing Anzhen Hospital
Collaborator
The Second Hospital University of South China
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Heze Municipal Hospital
Collaborator
Shenzhen People's Hospital, The Second Medical College of Jinan University
Collaborator
Liaocheng People's Hospital
Collaborator
Jining First People's Hospital
Collaborator
Weifang People's Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
Huai'an First People's Hospital
Collaborator
