The Role of Serum Anticholinergic Activity in ACVB Patients

January 13, 2010 updated by: Heidelberg University

Serum Anticholinergic Activity (SAA) and BIS-EEG as Potential Markers for Cognitive Ability and/or the Anticholinergic Medication in ACVB Patients

Drugs with anticholinergic potential increase the risk of postoperative transient and persistent cognitive dysfunction especially in cardiac patients. The investigators main goal is to identify preoperative risk factors and to monitor postoperative patients' state in relation to SAA activity and bilateral BIS-EEG changes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- BW
  - Heidelberg, BW, Germany, 69120
    - University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ACVB patients:

Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

written compliance to the study participation
a good knowledge in German speech
no red/ green blindness
no previous neurological and/or psychiatric illness
good ability to see and to hear
Mini-Mental-State-Examination (MMSE) better than 25 points

Exclusion Criteria:

no written compliance to the study participation
bad knowledge in German speech
red/ green blindness
previous neurological and/or psychiatric illness
no ability to see and to hear
Mini-Mental-State-Examination (MMSE) lower than 25 points

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
low SAA
high SAA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cognitive dysfunction measured by neurocognitive test battery Time Frame: 3 month postsurgery	3 month postsurgery

Secondary Outcome Measures

Outcome Measure	Time Frame
SAA, BIS-EEG, descriptive patients' characteristics Time Frame: 24 h postsurgery	24 h postsurgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

Study Chair: Eike Martin, Prof., Department of Anesthesiology, University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

ISPOCD1 study

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria