Hypoxic-Ischemic EncephalopathyPROPEA3NCT03485781
Propofol-induced EEG Changes in Hypoxic Brain Injury
An observational study of Hypoxic-Ischemic Encephalopathy and Cardiac Arrest, run by University of Oulu at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Cardiac Arrest
- How many people
- 102 participants
- Where
- 2 sitesFinland
- Study dates
- 12 Oct 2017to 10 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients admitted to intensive care in the study units.
Who may be able to join
- Comatose patients admitted to intensive care after cardiac arrest
Who cannot join
- Previous neurological disease expected to affect EEG substantially
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00029
Oulu University Hospital
Oulu, 90220
About this study
Official title: Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes
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.
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cardiac Arrest
- Keywords
- EEG, Intensive Care, Propofol
- Medical subject headings
- Hypoxia-Ischemia, Brain, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG slow-wave activity
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.
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 Oct 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, Helsinki University Central Hospital, Cerenion Oy
- Responsible party
- Sponsor
- Investigators
- Jukka Kortelainen, MD, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485781
- Sponsor's protocol ID
- 302/2016
- Acronym
- PROPEA3
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27749312
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes
- ClinicalTrials.gov ID
- NCT03485781
- Acronym / sponsor ID
- PROPEA3 / 302/2016
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cardiac Arrest
- Keywords
- EEG, Intensive Care, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital, Helsinki University Central Hospital, Cerenion Oy
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients admitted to intensive care in the study units.
Key inclusion criteria (1 listed)
- Comatose patients admitted to intensive care after cardiac arrest
Key exclusion criteria (1 listed)
- Previous neurological disease expected to affect EEG substantially
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 27749312Kortelainen 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.
- Individual participant dataSharing planned: No
Related trials for Hypoxic-Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jukka Kortelainen, MD, PhD principal investigator
University of Oulu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Cardiac Arrest, run by University of Oulu at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG slow-wave activity (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.