Multimodal Neurological Monitoring Strategy After Receiving ECPR

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest

• Registration Number: NCT06711016
• Lead Sponsor: Qilu Hospital of Shandong University

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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study Start: 2024-12-01
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2028-05-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 654

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
30-day survival rate with favorable neurological status	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.

Secondary Outcome Measures

Name	Time	Method
Survival with favorable neurological status at 3, 6 months	3 months, 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.
Time to return of circulation	Within 1 year	What is the time to return of circulation
Duration of mechanical ventilation	1 year	Is there a difference in the duration of mechanical ventilation between treatment groups
Length of stay at the ICU	1 year	Is there a difference in length of stay at the ICU between the treatment groups
Length of stay at the hospital	1 year	Is there a difference in length of stay at the hospital between the treatment groups
Duration of hypothermia	1 year	Is there a difference in duration of hypothermia between the treatment groups
Difference in NSE, S100 B level between treatment groups	3 days	Is there a difference in nerve damage Markers such as (1) NSE, (2) S100B at ROSC 24h, 48h, 72h between the treatment groups

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China