Clinical trial NCT06711016: Multimodal Neurological Monitoring Strategy After Receiving ECPR
Official title: Cerebral Perfusion and Oxygenation-oriented Multimodal Neurological Monitoring Strategy for Patients with Refractory Out-of -hospital Cardiac Arrest (OHCA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Keywords: Multimodality Neuromonitoring
ECPR
Out-of-hospital Caridac arrest
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Second Affiliated Hospital of Guangzhou Medical University
name: Second Affiliated Hospital of Zhengzhou University
First posted: 2024-12-02
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The control group: The goals of resuscitation include radial oxygen saturation between 92 and 98%, MAP ≥ 65 mmHg, Hb ≥ 7 g/dL, pH 7.35 to 7.45, and coagulation in accordance with ECMO management requirements. Routine fluid resuscitation, dehydration and intracranial pressure reduction, ECMO circulatory flow adjustment, temperature management, ventilator-supported ventilation, coronary angiography if coronary causes are suspected.

The experimental group：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 between 60%-70%, ONSD\<5.5mm, and the pathological state will be monitored with EEG by regulating the ECMO parameters, temperature treatment, ventilation, vasoactive agent, sedative and antiepileptic drug et al. if necessary. The rest were monitored and treated with the control group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 30-day survival rate with favorable neurological status
timeFrame: 30 days
Secondary outcomes:
measure: Survival with favorable neurological status at 3, 6 months
timeFrame: 3 months, 6 months
measure: Time to return of circulation
timeFrame: Within 1 year
measure: Duration of mechanical ventilation
timeFrame: 1 year
measure: Length of stay at the ICU
timeFrame: 1 year
measure: Length of stay at the hospital
timeFrame: 1 year
measure: Duration of hypothermia
timeFrame: 1 year
measure: Difference in NSE, S100 B level between treatment groups
timeFrame: 3 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yuguo Chen, MD. PhD
role: STUDY_CHAIR
References: