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NCT Number: NCT06601842

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICP monitoring

Device

ICP monitoring

Primary outcomes

  1. ICP difference between different temperature

    Time frame: 12 hour, day 1, 3, 7 post-ROSC

Secondary outcomes

  1. Difference between direct and non-invasive ICP monitoring indicators

    Time frame: 12 hour, day 1, 3, 7 post-ROSC

Study contacts

Contact information is provided by the study sponsor or research team.

Dean-An Ling, MD

CONTACT

[email protected]

+886-02-23123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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