Multimodal Neurological Monitoring Strategy After Receiving ECPR
- Conditions
- 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 memb...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 654
- Presumed or known to be 18-75 years old
- Witnessed OHCA
- Initially presenting with VF/VT or who have been administered an AED-shock
- Bystander CPR
- No flow time (time from CA to CPR) was less than 5 min
- Fail to achieve sustained ROSC within 15 minutes
- ROSC with sustained hemodynamic recovery within 15 minutes
- Terminal heart failure (NYHA III or IV), severe pulmonary disease (COPD Gold III or IV), oncological disease,
- Pregnancy
- Bilateral femoral bypass surgery
- Pre arrest Cerebral Performance Category (CPC) score of 3 or 4
- Multiple trauma (Injury Severity Score>15)
- 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