Multimodal Neurological Monitoring Strategy After Receiving ECPR (MNM-ECPR)

Cerebral Perfusion and Oxygenation-oriented Multimodal Neurological Monitoring Strategy for Patients with Refractory Out-of -hospital Cardiac Arrest (OHCA)

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.

The aim of this study is to test whether multimodal neuromonitoring will improve 30-day survival with a favorable neurologic outcome in ECPR patients with a refractory OHCA.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc

• Study Type: Interventional
• Enrollment (Estimated): 654
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xianfei Ji, MD. PhD; Phone Number: 0086-531-82165072; Email: qlyyjxf@163.com
• Study Contact Backup: Name: Feng Xu, MD. PhD; Phone Number: 86-0531-82165675; Email: xufengsdu@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu hospital
      • Contact: Xianfei Ji, MD, PhD; Phone Number: 0086-531-82165072; Email: qlyyjxf@163.com
      • Contact: Feng Xu, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Presumed or known to be 18-75 years old
2. Witnessed OHCA
3. Initially presenting with VF/VT or who have been administered an AED-shock
4. Bystander CPR
5. No flow time (time from CA to CPR) was less than 5 min
6. Fail to achieve sustained ROSC within 15 minutes

Exclusion Criteria:

1. ROSC with sustained hemodynamic recovery within 15 minutes
2. Terminal heart failure (NYHA III or IV), severe pulmonary disease (COPD Gold III or IV), oncological disease,
3. Pregnancy
4. Bilateral femoral bypass surgery
5. Pre arrest Cerebral Performance Category (CPC) score of 3 or 4
6. Multiple trauma (Injury Severity Score>15)
7. Estimated that cannulation will start 90 minutes after the initial arrest.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multimodal monitoring strategy; These include TCD to monitor cerebral blood perfusion levels, NIRS to monitor oxygen saturation levels in brain regions, ONSD to evaluate cerebral edema, and continuous quantitative EEG to monitor brain function to assess prognosis. Among them, The Vm will maintained between 56-85 cm/s, Vd>30cm/s，PI<1.2, the cerebral oxygen saturation (rSO2) in the brain region will maintained at 55%-75%, ONSD <5.5mm, and the pathological state will be monitored with EEG.	Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc; ECMO flow, IABP , ventilator support parameters, temperature management level and time; Other Names: Device
Active Comparator: control; SPO2 between 92 and 98%, MAP ≥ 65 mmHg, Hb ≥ 7 g/dL, pH 7.35 to 7.45, Pco2 between 40-45 mmHg， Routine fluid resuscitation, dehydration and intracranial pressure reduction, ECMO circulatory flow adjustment, temperature management, ventilator-supported ventilation, coronary angiography if coronary causes are suspected.	Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc; ECMO flow, IABP , ventilator support parameters, temperature management level and time; Other Names: Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day survival rate with favorable neurological status	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
Time to return of circulation	What is the time to return of circulation	Within 1 year
Length of stay at the ICU	Is there a difference in length of stay at the ICU between the treatment groups	1 year
Length of stay at the hospital	Is there a difference in length of stay at the hospital between the treatment groups	1 year
Duration of mechanical ventilation	Is there a difference in the duration of mechanical ventilation between treatment groups	1 year
Survival with favorable neurological status at 3, 6 months	Does multimodal neurological monitoring Strategy improve the neurological outcome at 3 months, 6 months. A Cerebral Performance Category (CPC) score of 1 or 2 indicates a favorable neurological status.	3 months, 6 months
Duration of hypothermia	Is there a difference in duration of hypothermia between the treatment groups	1 year
Difference in NSE, S100 B level between treatment groups	Is there a difference in nerve damage Markers such as (1) NSE, (2) S100B at ROSC 24h, 48h, 72h between the treatment groups	3 days

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The First Affiliated Hospital of Zhengzhou University; China-Japan Friendship Hospital; Second Affiliated Hospital of Zhengzhou University; Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Yuguo Chen, MD. PhD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• 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 (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ECPR; Multimodality Neuromonitoring; Out-of-hospital Caridac arrest
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Analgesics; Chrysarobin; Hypnotics and Sedatives; Anticonvulsants
• Other Study ID Numbers: KYLL-202409-012-1

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