NCT03641833

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 15, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

July 15, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

cardiacsurgerypostoperative cognitive dysfunctionbypassbrain biomarkerstranscranial Doppler

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.

    3 years

  • Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.

    3 years

Other Outcomes (1)

  • Determine factors causing POCD

    3 years

Interventions

Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.

Also known as: device

Eligibility Criteria

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

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

You may qualify if:

  • Coronary artery bypass grafting or/and heart valve surgery;
  • Patients age\>18years
  • Cardiac output \>35%

You may not qualify if:

  • Patient disagreement;
  • Diseases causing cognitive dysfunction;
  • Multi organic deficiency;
  • Agents affecting central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Outside US/Canada/Australia, 50221, Lithuania

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Edmundas Sirvinskas, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician anaesthesiologist

Study Record Dates

First Submitted

July 15, 2018

First Posted

August 22, 2018

Study Start

August 2, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations