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

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ClinicalTrials.gov Identifier: NCT03485781
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Oulu University Hospital
Helsinki University Central Hospital
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.

Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : October 12, 2018
Estimated Study Completion Date : April 12, 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.



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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


Contacts
Contact: Jukka Kortelainen, MD, PhD +358 50 4474909 jukka.kortelainen@oulu.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Johanna Hästbacka, MD, PhD    +358 50 4286701    johanna.hastbacka@hus.fi   
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Jukka Kortelainen, MD, PhD    +358 50 4474909    jukka.kortelainen@oulu.fi   
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Helsinki University Central Hospital
Investigators
Principal Investigator: Jukka Kortelainen, MD, PhD University of Oulu

Publications:
Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03485781     History of Changes
Other Study ID Numbers: 302/2016
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Craniocerebral Trauma
Brain Injuries
Heart Arrest
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Hypoxia, Brain
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics