NCT07875348

Brief Summary

Neurological outcome is the primary outcome for post-cardiac arrest patients. Hypoxic-ischemic brain injury is a key element in post-cardiac arrest syndrome, and remains the leading cause of mortality and morbidity in post-cardiac arrest patients. In patients with hypoxic-ischemic brain injury, impaired cerebral autoregulation makes cerebral blood flow highly vulnerable to blood pressure fluctuations, which might trigger secondary brain injuries. Although the pressure reactivity index (PRx) calculated via invasive intracranial pressure (ICP) monitoring is considered the gold standard for assessing cerebral autoregulation, its clinical application in post-cardiac arrest patients is limited due to invasive risks. Alternatively, cerebral near-infrared spectroscopy (NIRS) combined with hemodynamic monitoring offers a non-invasive approach to measure the cerebral oxygenation index (COx). However, its consistency with invasive methods and its accuracy in post-cardiac arrest care warrant further validation. The aim of this study is to assess cerebral autoregulation via COx calculated with NIRS and hemodynamic parameters in post-cardiac arrest patients, and to analyze the impact of this index on neurological outcomes. The further goal is to estimate optimal mean arterial pressure (MAPopt) and subsequently establish personalized post-resuscitation blood pressure targets.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
37mo left

Started Jan 2027

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

2.6 years

First QC Date

October 5, 2026

Last Update Submit

October 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neurological Outcome

    Cerebral Performance Category Scale (1-5), higher scores mean a worse outcome

    up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

post-cardiac arrest patients admitted to ICU

You may qualify if:

  • non-traumatic cardiac arrest
  • admitted to ICU
  • unable to follow verbal instructions (GCS: motor \<=5)

You may not qualify if:

  • traumatic cardiac arrest
  • pregnancy
  • cognitive impairment before cardiac arrest (CPC scale \>=3)
  • severe peripheral artery diseases
  • Raynaud's syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dean-An Ling

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 15, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

October 15, 2026

Record last verified: 2026-10

Locations