NCT04506788

Brief Summary

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 3, 2020

Last Update Submit

August 6, 2020

Conditions

Hypoxic-Ischemic EncephalopathyCardiac Arrest

Keywords

EEGIntensive CarePropofol

Outcome Measures

Primary Outcomes (1)

  • EEG slow wave activity

    EEG slow-wave activity determined from the low-frequency (\<1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours.

    0-72 hours

Eligibility Criteria

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

All eligible patients admitted to intensive care in the study units.

You may qualify if:

  • Comatose patients admitted to intensive care after cardiac arrest

You may not qualify if:

  • Previous neurological disease expected to affect EEG substantially

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (2)

  • Kortelainen J, Vayrynen E, Juuso I, Laurila J, Koskenkari J, Ala-Kokko T. Forehead electrodes sufficiently detect propofol-induced slow waves for the assessment of brain function after cardiac arrest. J Clin Monit Comput. 2020 Feb;34(1):105-110. doi: 10.1007/s10877-019-00282-3. Epub 2019 Feb 20.

    PMID: 30788811BACKGROUND

  • Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. doi: 10.1097/ALN.0000000000001385.

    PMID: 27749312BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainHeart Arrest

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart Diseases

Study Officials

  • Jukka Kortelainen, MD, PhD

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 10, 2020

Study Start

June 15, 2015

Primary Completion

June 12, 2017

Study Completion

June 12, 2017

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)