Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR

Qilu Hospital of Shandong University654 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

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

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 ECPROTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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

Time frame: 30 days and 90 days

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

Time frame: 90 days

Duration of mechanical ventilation

Is there a difference in the duration of mechanical ventilation between treatment groups

Time frame: 1 year

Length of stay at the ICU

Is there a difference in length of stay at the ICU between the treatment groups

Time frame: 1 year

Length of stay at the hospital

Is there a difference in length of stay at the hospital between the treatment groups

Time frame: 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

Time frame: 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

Time frame: 1 year

ECMO duration

Is there a difference in the duration of ECMO between treatment groups

Time frame: 1 year

Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts