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

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

Interventions

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, 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.

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• The Second Hospital University of South China

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Heze Municipal Hospital

  collaborator OTHER

• Shenzhen People's Hospital, The Second Medical College of Jinan University

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  lead OTHER

Principal Investigators

• Yuguo Chen, MD. PhD · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-22

Primary Completion

2028-05-30

Completion

2028-07-30

Countries

• China

Study Locations