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Propofol-induced EEG Changes in Hypoxic Brain Injury (PROPEA3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485781
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Oulu University Hospital
Helsinki University Central Hospital
Cerenion Oy
Information provided by (Responsible Party):
University of Oulu

Brief Summary:
PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.

Condition or disease
Hypoxic-Ischemic Encephalopathy Cardiac Arrest

Detailed Description:
PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially EEG are excluded. The patients' relatives are asked for an informed written consent to participate. In the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the ICUs' common practice. EEG is recorded continuously from the admission to the ICU until 48 hours from the cardiac arrest. EEG slow-wave activity is determined offline by calculating the low-frequency (<1 Hz) power from the signal. The neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/relative using Cerebral Performance Category. After the follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate the health and quality of life.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol




Primary Outcome Measures :
  1. EEG slow-wave activity [ Time Frame: 0-48 hours ]
    EEG slow-wave activity defined by the low-frequency (<1 Hz) signal power calculated continuously from the beginning of EEG measurement until 48 hours from cardiac arrest. The study investigates the association between the slow-wave activity and neurological outcome i.e. Cerebral Performance Category after 6 month follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients admitted to intensive care in the study units.
Criteria

Inclusion Criteria:

  • Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria:

  • Previous neurological disease expected to affect EEG substantially

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485781


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Oulu University Hospital
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Helsinki University Central Hospital
Cerenion Oy
Investigators
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Principal Investigator: Jukka Kortelainen, MD, PhD University of Oulu
Publications:
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03485781    
Other Study ID Numbers: 302/2016
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oulu:
EEG
Intensive Care
Propofol
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Hypoxia
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Hypoxia, Brain