The Role of Serum Anticholinergic Activity in ACVB Patients | NCT00782938

Studies
The Role of Serum Anticholinergic Activity in ACVB Patients

NCT00782938

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Jan 14, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Acetylcholine
Cognition
BIS-EEG

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 30, 2008

First Submission Date that Met QC Criteria

Oct 30, 2008

First Posted Date

Oct 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2010

Last Update Posted Date

Jan 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

ACVB patients:

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eike Martin, Prof.	Department of Anesthesiology, University of Heidelberg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School		Heidelberg	Baden-Wurttemberg	69120	Germany

Label	Type	Description	Intervention Names
low SAA
high SAA