Cardiac Arrest
Conditions
Keywords
Multimodality Neuromonitoring, ECPR, Out-of-hospital Caridac arrest, In-Hospital Cardiac Arrest
Brief summary
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.
Interventions
OTHERif rSO2 < 58%
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
OTHERif rSO2 58%-68%
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
OTHERrSO2>68%
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
OTHERStandard monitoring 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 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.
OTHERStandard monitoring based on ECPR
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.
Sponsors
Qilu Hospital of Shandong University
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
Second Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Hunan Provincial People's Hospital
Jiangsu Provincial People's Hospital
The Affiliated Hospital of Qingdao University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Anzhen Hospital
The Second Hospital University of South China
The Affiliated Hospital of Xuzhou Medical University
Heze Municipal Hospital
Shenzhen People's Hospital, The Second Medical College of Jinan University
Liaocheng People's Hospital
Jining First People's Hospital
Weifang People's Hospital
The First People's Hospital of Lianyungang
Huai'an First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18-75 years old 2. Witnessed in-hospital or out-of-hospital cardiac arrest 3. 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 4. Time from cardiac arrest to initiation of CPR \< 10 minutes 5. The cause of cardiac arrest is expected to be reversible (e.g., hypothermia, acute myocardial infarction/myocardial ischemia, malignant arrhythmia, pulmonary embolism, electrolyte abnormalities, hypoxia, anaphylactic shock, hemorrhage/hypovolemia, drug poisoning, electric shock, etc.)
Exclusion criteria
1. Aortic dissection 2. Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation 3. Pregnancy 4. Severe trauma 5. Cerebral Performance Category (CPC) score \> 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.) 6. Terminal diseases, such as malignant tumors, end-stage liver and kidney diseases, severe heart failure (NYHA class III or IV), severe COPD (GOLD class III or IV), etc. 7. Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) \> 90 minutes 8. Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable neurological outcome (CPC scale 1-2) at 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to 30 days and 90 days; | 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; | 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 | 1 year | Is there a difference in the duration of mechanical ventilation between treatment groups |
| Length of stay at the ICU | 1 year | Is there a difference in length of stay at the ICU between the treatment groups |
| Length of stay at the hospital | 1 year | Is there a difference in length of stay at the hospital between the treatment groups |
| Difference in NSE level between treatment groups | 3 days | Is there a difference in nerve damage Markers such as NSE at ROSC 24h, 48h, 72h between the treatment groups |
| ECMO-related complication rates such as hemorrhage, infarction, lower limb ischemic necrosis, etc. | 1 year | Is there a difference in ECMO-related complication between the treatment groups |
| ECMO duration | 1 year | Is there a difference in the duration of ECMO between treatment groups |
Countries
China
Contacts
CONTACTXianfei Ji, MD. PhD
CONTACTFeng Xu, MD. PhD
STUDY_CHAIRYuguo Chen, MD. PhD
Qilu Hospital of Shandong University
Outcome results
None listed