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

• Conditions: Postoperative Cognitive Dysfunction

• Registration Number: NCT03641833
• Lead Sponsor: Rasa Bukauskiene

Brief 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

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 Timeline

• Study First Submitted: 2018-07-15
• Status Verified: 2018-08
• Study Start: 2018-08-02
• Study First Submitted QC: 2018-08-20
• Last Update Submitted: 2018-08-20
• Study First Posted: 2018-08-22
• Last Update Posted: 2018-08-22
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain blood flow speed changes during surgery and correlation with POCD	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).

Secondary Outcome Measures

Name	Time	Method
Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.	3 years	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
Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.	3 years	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

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Outside US/Canada/Australia, Lithuania