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

NCT06711016 | Recruiting DMC

• 1 other identifier: KYLL-2025-09-586-1
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Arrest

Keywords

Multimodality Neuromonitoring; ECPR; Out-of-hospital Caridac arrest; In-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (8)

• Survival to 30 days and 90 days;

  30 days and 90 days

• Favorable neurological outcome (CPC 1-2) at 90 days;

  90 days

• Duration of mechanical ventilation

  1 year

• Length of stay at the ICU

  1 year

• Length of stay at the hospital

  1 year

Study Arms (2)

control

ACTIVE COMPARATOR

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).

Multimodal monitoring strategy

EXPERIMENTAL

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%; Other: if rSO2 58%-68%; Other: rSO2>68%; Other: Standard monitoring based on ECPR

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

Multimodal monitoring strategy

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

Multimodal monitoring strategy

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

Multimodal monitoring strategy

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.

control

Standard monitoring based on ECPR 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.

Multimodal monitoring strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• Aortic dissection
• Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation
• Pregnancy
• Severe trauma
• Cerebral Performance Category (CPC) score \> 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.)
• 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.
• Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) \> 90 minutes
• Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• 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
• Hunan Provincial People's Hospital: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Heze Municipal Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Jining First People's Hospital: collaborator
• Weifang People's Hospital: collaborator
• Huai'an First People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The Second Hospital University of South China: collaborator
• Shenzhen People's Hospital, The Second Medical College of Jinan University: collaborator
• The First People's Hospital of Lianyungang: collaborator

Study Sites (2)

Qilu Hospital

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Qilu hospital

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yuguo Chen, MD. PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Xianfei Ji, MD. PhD

CONTACT

0086-531-82165072; qlyyjxf@163.com

Feng Xu, MD. PhD

CONTACT

86-0531-82165675; xufengsdu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The control group: Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions). Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults. including regulating ECMO blood flow, the dose of vasoactive drugs , mechanical ventilation parameters, sedation and analgesia plans. The experimental group：For patients with refractory cardiac arrest undergoing ECPR, continuous cerebral oxygenation monitoring was used. Guided by the target-directed management strategies targeting cerebral oxygenation, interventions were dynamically adjusted. These adjustments included modifying ECMO blood flow rates, titrating vasoactive drug dosages, optimizing mechanical ventilation parameters, administering osmotic dehydration therapy, using antiepileptic drugs, and implementing targeted temperature management.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 2, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)