Monitoring and Optimization of Cerebral Perfusion Pressure in Post-cardiac Arrest Patients: a Pilot Study

December 11, 2024 updated by: National Taiwan University Hospital

The goal of this study is to establish the ICP and CPP monitoring process and analyze the results in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis.

Participants will receive ICP monitoring within 12 hours post-ROSC if meet all inclusion and exclusion criteria.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-resuscitation care after cardiac arrest is an important emergency and critical care issue. The post-arrest care after the return of spontaneous circulation has also been incorporated into the chain of survival and resuscitation guidelines. After the regain of spontaneous circulation, cardiac arrest patients will face the challenges of post-arrest syndrome, which includes post-anoxic brain injury, myocardial dysfunction, systemic ischemia-reperfusion, and persistent precipitating causes. The hypoxic brain injury will impair the autoregulation of cerebral blood vessels, thereby affecting the adjustment of intracranial pressure (ICP) and causing cerebral edema. High-quality post-arrest care including targeted temperature management, optimization of hemodynamics and respiratory care, control of blood sugar, monitoring and treatment of epilepsy, etc. The goal is to achieve neuroprotective effects and improve patient outcomes.

The modalities that currently have more evidence for neurocritical care and neuroprognosis include electroencephalogram (EEG) monitoring, pupillary light reflex, brain imaging such as computed tomography (CT) and magnetic resonance imaging (MRI), somatosensory evoked potentials (SSEP), and serum biomarkers such as neuron-specific enolase (NSE), etc. Direct ICP monitoring is not routinely used in cardiac arrest patients due to a lack of clinical experience and concurrent use of antiplatelet medications or anticoagulants. The application of ICP monitoring in neurocritical care can be based on the experience of traumatic brain injury. ICP monitoring can facilitate early detection, determination of treatment strategies, and prediction of outcomes. Cerebral perfusion pressure (CPP) can also be obtained by ICP monitoring. Current head injury treatment guidelines recommend maintaining CPP at around 60-70 mmHg. However, there are no current recommendations for CPP standards for post-arrest patients. In recent years, there have been studies on the utilization of the pressure reactivity index to identify the optimized CPP in patients with traumatic brain injury, but not yet applicated in post-arrest patients.

This study aims to establish the ICP and CPP monitoring process and analyze the result in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • non-traumatic cardiac arrest
  • admitted to ICU
  • GCS: motor <=5
  • severity: TIMECARD score medium-risk group

Exclusion Criteria:

  • traumatic cardiac arrest
  • pregnancy
  • intracranial hemorrhage
  • coagulopathy
  • anti-platelet or anti-coagulation use
  • terminal illness
  • pre-arrest CPC score >=3
  • GWR < 1.2 on CT or severe hypoxic ischemic encephalopathy
  • CNS infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP monitoring
Device: ICP monitoring
ICP monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICP difference between different temperature
Time Frame: 12 hour, day 1, 3, 7 post-ROSC
12 hour, day 1, 3, 7 post-ROSC

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between direct and non-invasive ICP monitoring indicators
Time Frame: 12 hour, day 1, 3, 7 post-ROSC
12 hour, day 1, 3, 7 post-ROSC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Dean-An Ling, MD, National Taiwan University Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 14, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202407092RINE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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