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Efficacy and Safety of Target-directed Management of Cerebral Oxygenation in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation: A Multicenter, Pragmatic, Randomized, Controlled Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• 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.)

Locations
Other Locations
China
Qilu hospital
RECRUITING
Jinan
Qilu Hospital
NOT_YET_RECRUITING
Jinan
Contact Information
Primary
Xianfei Ji, MD. PhD
qlyyjxf@163.com
0086-531-82165072
Backup
Feng Xu, MD. PhD
xufengsdu@126.com
86-0531-82165675
Time Frame
Start Date: 2025-04-22
Estimated Completion Date: 2028-07-30
Participants
Target number of participants: 654
Treatments
Active_comparator: control
Standard monitoring (including vital signs monitoring, blood gas analysis, and lactate levels) 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 between 32 and 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.
Experimental: Multimodal monitoring strategy
Experimental group: In addition to standard treatment in the control group, a multimodal monitoring system of brain function is integrated: continuous rSO2 monitoring with at least once-daily TCD for cerebral blood flow velocity monitoring, ONSD ultrasound measurement, and EEG monitoring. Based on the cerebral oxygenation target-directed management strategies, intervention measures such as the ECMO blood flow, the dose of vasoactive drugs, mechanical ventilation parameters, target temperature management, sedation and analgesia plans, and antiepileptic drugs are dynamically adjusted to ultimately achieve the goal of brain oxygenation target value (rSO2) to 58%-68%.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Provincial People's Hospital, Beijing Anzhen Hospital, Liaocheng People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jining First People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Weifang People's Hospital, Shenzhen People's Hospital, The Second Medical College of Jinan University, Huai'an First People's Hospital, The Affiliated Hospital of Qingdao University, The First People's Hospital of Lianyungang, Second Affiliated Hospital of Guangzhou Medical University, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangsu Provincial People's Hospital, The Second Hospital University of South China, Guangdong Provincial People's Hospital, Heze Municipal Hospital, Second Affiliated Hospital of Zhengzhou University
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov