AcetylcholineNCT00782938
The Role of Serum Anticholinergic Activity in ACVB Patients
An observational study of Acetylcholine and Cognition, run by Heidelberg University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Acetylcholine, Cognition, BIS-EEG
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACVB patients: Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
- Conditions
- Acetylcholine, Cognition, BIS-EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low SAA | Not described | |
| high SAA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive dysfunction measured by neurocognitive test battery
Measured: 3 month postsurgery
Secondary outcomes (1)
SAA, BIS-EEG, descriptive patients' characteristics
Measured: 24 h postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcetylcholineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Eike Martin, Prof., Study chair, Department of Anesthesiology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782938
- Sponsor's protocol ID
- S235-2008
- Status last verified
- Oct 2008
- First submitted
- 30 Oct 2008
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Anticholinergic Activity (SAA) and BIS-EEG as Potential Markers for Cognitive Ability and/or the Anticholinergic Medication in ACVB Patients
- ClinicalTrials.gov ID
- NCT00782938
- Acronym / sponsor ID
- S235-2008
- Conditions
- Acetylcholine, Cognition, BIS-EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low SAA | – | – |
| high SAA | – | – |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACVB patients: Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive dysfunction measured by neurocognitive test battery
Time frame: 3 month postsurgery
1 secondary outcome
SAA, BIS-EEG, descriptive patients' characteristics
Time frame: 24 h postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- ISPOCD1 studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eike Martin, Prof. study chair
Department of Anesthesiology, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetylcholine and Cognition, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive dysfunction measured by neurocognitive test battery (time frame: 3 month postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.