Multimodal Neurological Monitoring Strategy After Receiving ECPR

NCT06711016 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-202409-012-1
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Multimodality Neuromonitoring; ECPR; Out-of-hospital Caridac arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Survival with favorable neurological status at 3, 6 months

  3 months, 6 months

• Time to return of circulation

  Within 1 year

• Duration of mechanical ventilation

  1 year

• Length of stay at the ICU

  1 year

• Length of stay at the hospital

  1 year

Study Arms (2)

multimodal monitoring strategy

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

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

Interventions

fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc OTHER

ECMO flow, IABP , ventilator support parameters, temperature management level and time

Also known as: Device

control; multimodal monitoring strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• Second Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Anticonvulsants; Equipment and Supplies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yuguo Chen, MD. PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Xianfei Ji, MD. PhD

CONTACT

0086-531-82165072; qlyyjxf@163.com

Feng Xu, MD. PhD

CONTACT

86-0531-82165675; xufengsdu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: December 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)