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

June 3, 2026 updated by: Feng Xu, Qilu Hospital of Shandong University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

654

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xianfei Ji, MD. PhD
  • Phone Number: 0086-531-82165072
  • Email: qlyyjxf@163.com

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu hospital
        • Contact:
        • Contact:
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu hospital
        • Contact:
          • Xianfei Ji, MD, PhD
          • Phone Number: 0086-531-82165072
          • Email: qlyyjxf@163.com
        • Principal Investigator:
          • Feng Xu, MD. PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Standard 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.
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%.
Other: if 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
Other: if 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
Other: rSO2>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
Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorable neurological outcome (CPC scale 1-2) at 30 days
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay at the ICU
Time Frame: 1 year
Is there a difference in length of stay at the ICU between the treatment groups
1 year
Length of stay at the hospital
Time Frame: 1 year
Is there a difference in length of stay at the hospital between the treatment groups
1 year
Duration of mechanical ventilation
Time Frame: 1 year
Is there a difference in the duration of mechanical ventilation between treatment groups
1 year
Survival to 30 days and 90 days;
Time Frame: 30 days and 90 days
Does multimodal neurological monitoring Strategy improve the survival rates of 30 days and 90 days after cardiac arrest
30 days and 90 days
Favorable neurological outcome (CPC 1-2) at 90 days;
Time Frame: 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
90 days
Difference in NSE level between treatment groups
Time Frame: 3 days
Is there a difference in nerve damage Markers such as NSE at ROSC 24h, 48h, 72h between the treatment groups
3 days
ECMO-related complication rates such as hemorrhage, infarction, lower limb ischemic necrosis, etc.
Time Frame: 1 year
Is there a difference in ECMO-related complication between the treatment groups
1 year
ECMO duration
Time Frame: 1 year
Is there a difference in the duration of ECMO between treatment groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
China-Japan Friendship Hospital
Hunan Provincial People's Hospital
Second Affiliated Hospital of Zhengzhou University
Second Affiliated Hospital of Guangzhou Medical University
The Affiliated Hospital of Xuzhou Medical University
The First People's Hospital of Lianyungang
Jiangsu Provincial People's Hospital
Liaocheng People's Hospital
Weifang People's Hospital
Huai'an First People's Hospital
Shenzhen People's Hospital, The Second Medical College of Jinan University
The Second Hospital University of South China
Heze Municipal Hospital
Jining First People's Hospital

Investigators

  • Study Chair: Yuguo Chen, MD. PhD, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-2025-09-586-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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