Delirium - PostoperativeNCT06967779
The Relationship Between Delirium and BDNF in Coronary Artery Bypass Graft Surgery
An observational study of Delirium - Postoperative and BDNF, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
This study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (BDNF) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative, BDNF, CABG
- How many people
- 107 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2021to 1 Jul 2024
- 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: A prospective observational cohort study will recruit 200 patients scheduled for planned coronary artery bypass grafting (CABG), with the use of cardio-pulmonary by-pass who will be operated at the Cardiac Surgery Department of the Pomeranian Medical University in Szczecin. The Cardiac Surgery Department of Pomeranian Medical University has a volume of 900-1100 operations per year, 70% being CABG (approx. 700 CABG operations per year).
Who may be able to join
- Age > 18 years.
- Planned coronary artery bypass grafting (CABG) procedure with the use of cardiopulmonary by-pass (CPB).
- Ability to understand and sign an informed consent form.
Who cannot join
- Emergency surgery.
- Previous known cognitive disorders: Mini Mental State Examination (MMSE) score <15.
- Baseline delirium (positive CAM test prior to surgery).
- Diagnosis of psychiatric syndromes in the past - i.e. depression, dementia, psychosis or schizophrenia.
- Inability to understand Polish language.
- Inability to give and sign informed consent due to auditory or visual dysfunction.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, West Pomeranian Voivodeship, 70-111
About this study
Official title: Analysis of the Relationship Between the Concentration of the Brain Derived Neurotrophic Factor (BDNF) in Plasma, the Occurrence of BDNF Gene Polymorphism (Val66Met) and White Blood Cell Markers and the Incidence of Postoperative Central Nervous System Disorders in Patients Undergoing General Anesthesia for Cardiac Surgery With Extracorporeal Circulation
This study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (BDNF) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in patients undergoing coronary artery bypass grafting (CABG) carrying BDNF gene polymorphism (Val66Met).
- Conditions
- Delirium - Postoperative, BDNF, CABG
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
The main aim of the study will be to assess the correlation between brain function disorders, defined as abnormal BDNF levels, and postoperative delirium.
Measured: Up to a year after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jul 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kacper Lechowicz, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967779
- Sponsor's protocol ID
- delirium CABG
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between the Concentration of the Brain Derived Neurotrophic Factor (BDNF) in Plasma, the Occurrence of BDNF Gene Polymorphism (Val66Met) and White Blood Cell Markers and the Incidence of Postoperative Central Nervous System Disorders in Patients Undergoing General Anesthesia for Cardiac Surgery With Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT06967779
- Acronym / sponsor ID
- delirium CABG
- Conditions
- Delirium - Postoperative, BDNF, CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 May 2025 (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.
This study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (BDNF) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in patients undergoing coronary artery bypass grafting (CABG) carrying BDNF gene polymorphism (Val66Met).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective observational cohort study will recruit 200 patients scheduled for planned coronary artery bypass grafting (CABG), with the use of cardio-pulmonary by-pass who will be operated at the Cardiac Surgery Department of the Pomeranian Medical University in Szczecin. The Cardiac Surgery Department of Pomeranian Medical University has a volume of 900-1100 operations per year, 70% being CABG (approx. 700 CABG operations per year).
Key inclusion criteria (3 listed)
- Age > 18 years.
- Planned coronary artery bypass grafting (CABG) procedure with the use of cardiopulmonary by-pass (CPB).
- Ability to understand and sign an informed consent form.
Key exclusion criteria (6 listed)
- Emergency surgery.
- Previous known cognitive disorders: Mini Mental State Examination (MMSE) score <15.
- Baseline delirium (positive CAM test prior to surgery).
- Diagnosis of psychiatric syndromes in the past - i.e. depression, dementia, psychosis or schizophrenia.
- Inability to understand Polish language.
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
The main aim of the study will be to assess the correlation between brain function disorders, defined as abnormal BDNF levels, and postoperative delirium.
Time frame: Up to a year after the procedure.
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 15 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and BDNF, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 3 inclusion and 6 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The main aim of the study will be to assess the correlation between brain function disorders, defined as abnormal BDNF levels, and postoperative delirium. (time frame: Up to a year after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.