NCT06967779

Brief 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 patients undergoing coronary artery bypass grafting (CABG) carrying BDNF gene polymorphism (Val66Met).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 4, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The main aim of the study will be to assess the correlation between brain function disorders, defined as abnormal BDNF levels, and postoperative delirium.

    Up to a year after the procedure.

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 13, 2025

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations