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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Aortic dissection

Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation

Pregnancy

Severe trauma

Trial design

Treatments tested in this trial

  • 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

Treatment groups

654 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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