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

RecruitingNAAges 18 Years - 75 YearsAllQilu Hospital of Shandong University
NCT06711016 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 cerebrovas

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📋 Eligibility rules (as published)
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
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What it tests

  • if rSO2 < 58%
  • if rSO2 58%-68%
  • rSO2>68%
  • Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results).
  • Standard monitoring based on ECPR
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Where

2 sites
Qilu Hospital
Jinan, China
Qilu hospital
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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