Postoperative Cognitive DysfunctionNCT03641833
Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB
An observational study of Postoperative Cognitive Dysfunction, run by Rasa Bukauskiene at 1 site in Lithuania.
Trial summary
The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- blood sample for brain biomarkers
- How many people
- 130 participants
- Where
- 1 siteLithuania
- Study dates
- 2 Aug 2018to Sep 2021
- 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: Study include patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences
Who may be able to join
- Coronary artery bypass grafting or/and heart valve surgery;
- Patients age>18years
- Cardiac output >35%
Who cannot join
- Patient disagreement;
- Diseases causing cognitive dysfunction;
- Multi organic deficiency;
- Agents affecting central nervous system
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, Outside US/Canada/Australia, 50221
Rasa Bukauskiene, 867111033, rasa.bukauskiene@lsmuni.lt
About this study
Official title: Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most important
Read the detailed description
Prospective case-control study included patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences. Inclusion criteria is: 1) cardiac output > 35%; 2) no agents affecting central nervous system; 3) no neuropathology; 5) no multiple organ dysfunction. Patients will have to perform mini mental state examination (MMSE), Trial making, addenbrooke tests before and 7 days after surgery. Brain biomarkers glial fibrillary acid protein (GFAP) and neurofilaments will be taken after induction, 24 and 48 hours after surgery. Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.
After these test, the investigators are going to examine data about patient and operation, recognize factors causing POCD and identify the most important of them.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- blood sample for brain biomarkers
- Keywords
- cardiac, surgery, postoperative cognitive dysfunction, bypass, brain biomarkers, transcranial Doppler
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample for brain biomarkersDiagnostic test
Also called device
Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain blood flow speed changes during surgery and correlation with POCD
Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery using the 2MHz TCD ultrasound transducer over the temporal area. By adjusting the probe the curve of arteria will appear. Target measurement- mean flow velocity (MFV is measured in cm/s).
Measured: 3 years
Secondary outcomes (2)
Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.
Blood sample for brain biomarkers GFAP will be taken after induction, 24 and 48 hours after surgery. GFAP concentration in blood serum is measured in ng/ml
Measured: 3 years
Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.
Blood sample for brain biomarker neurofilaments will be taken after induction, 24 and 48 hours after surgery. GFAP concentration in blood serum is measured in pg/ml
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start2 Aug 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rasa Bukauskiene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasa Bukauskiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641833
- Sponsor's protocol ID
- POCD-1
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT03641833
- Acronym / sponsor ID
- POCD-1
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- cardiac, surgery, postoperative cognitive dysfunction, bypass, brain biomarkers, transcranial Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Rasa BukauskieneUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Aug 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.
The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most important
Detailed description
Prospective case-control study included patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences. Inclusion criteria is: 1) cardiac output > 35%; 2) no agents affecting central nervous system; 3) no neuropathology; 5) no multiple organ dysfunction. Patients will have to perform mini mental state examination (MMSE), Trial making, addenbrooke tests before and 7 days after surgery. Brain biomarkers glial fibrillary acid protein (GFAP) and neurofilaments will be taken after induction, 24 and 48 hours after surgery. Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.
After these test, the investigators are going to examine data about patient and operation, recognize factors causing POCD and identify the most important of them.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study include patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences
Key inclusion criteria (3 listed)
- Coronary artery bypass grafting or/and heart valve surgery;
- Patients age>18years
- Cardiac output >35%
Key exclusion criteria (4 listed)
- Patient disagreement;
- Diseases causing cognitive dysfunction;
- Multi organic deficiency;
- Agents affecting central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample for brain biomarkersAlso: deviceTranscranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery. | Diagnostic test | – |
Primary outcome
Brain blood flow speed changes during surgery and correlation with POCD
Time frame: 3 years
Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery using the 2MHz TCD ultrasound transducer over the temporal area. By adjusting the probe the curve of arteria will appear. Target measurement- mean flow velocity (MFV is measured in cm/s).
2 secondary outcomes
Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.
Time frame: 3 years
Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Postoperative Cognitive Dysfunction, run by Rasa Bukauskiene at 1 site in Lithuania.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasa Bukauskiene (867111033, rasa.bukauskiene@lsmuni.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain blood flow speed changes during surgery and correlation with POCD (time frame: 3 years). 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 22 Aug 2018.