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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Diagnostic test: blood sample for brain biomarkers

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 Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Rasa Bukauskiene; Phone Number: 867111033; Email: rasa.bukauskiene@lsmuni.lt
• Study Contact Backup: Name: Edmundas Sirvinskas, Professor; Phone Number: +37037326171; Email: edmundas.sirvinskas@lsmuni.lt

Study Locations

• Lithuania
  • Outside US/Canada/Australia
    • Kaunas, Outside US/Canada/Australia, Lithuania, 50221
      • Recruiting
      • Lithuanian University of Health Sciences
      • Contact: Rasa Bukauskiene; Phone Number: 867111033; Email: rasa.bukauskiene@lsmuni.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study include patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rasa Bukauskiene

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: surgery; cardiac; postoperative cognitive dysfunction; bypass; transcranial Doppler; brain biomarkers
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: POCD-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No