Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641833
• Other study ID #: POCD-1
• Status: Recruiting
• Start date: August 2, 2018
• Est. completion date: September 2021

Study information

• Verified date: August 2018
• Source: Lithuanian University of Health Sciences
• Contact: Rasa Bukauskiene
• Phone: 867111033
• Email: rasa.bukauskiene[@]lsmuni.lt
• Is FDA regulated: No
• Study type: Observational

Clinical 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 important

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Coronary artery bypass grafting or/and heart valve surgery;

• Patients age>18years

• Cardiac output >35%

Exclusion Criteria:

• Patient disagreement;

• Diseases causing cognitive dysfunction;

• Multi organic deficiency;

• Agents affecting central nervous system

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Diagnostic Test:
• blood sample for brain biomarkers
Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas	Outside US/Canada/Australia

Sponsors (1)

Lead Sponsor	Collaborator
Rasa Bukauskiene

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine factors causing POCD	Patients will complete questionares: mini mental state examination (MMSE), Trial making and addenbrooke test one day before and 10 days after the surgery. We are going to compare change in tests results after surgery and find correlation with brain biomarkers and blood flow speed during surgery	3 years
Primary	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).	3 years
Secondary	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	3 years
Secondary	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	3 years