Postoperative DeliriumNCT00463333
Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers
An observational study of Postoperative Delirium, run by Heidelberg University at 1 site in Germany.
Trial summary
Summary: Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- May 2005to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients at Intensive Care Unit over a defined time period
- Over 18 years old
Who cannot join
- Elective heart and vascular patients
Trial locations and contacts
1 site in 1 country.
Germany1 site
Intensive Care Unit, Clinic of Anesthesiology
Heidelberg, Heidelberg, 69120
About this study
Summary:
Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, psychometric testing, EEG, serum markers
- Medical subject headings
- Emergence Delirium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Investigators
- Markus A Weigand, PhD, MD, Principal investigator, Medical Faculty, Clinic of Anesthesiology, University of HeidelbergKonstanze Plaschke, Prof., Principal investigator, Clinic of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463333
- Sponsor's protocol ID
- 196/2004
- Status last verified
- Apr 2007
- First submitted
- 10 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Plaschke K, Kopitz J, Mattern J, Martin E, Teschendorf P. Increased cortisol levels and anticholinergic activity in cognitively unimpaired patients. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):433-41. doi: 10.1176/jnp.2010.22.4.433.
PubMed 21037129
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers
- ClinicalTrials.gov ID
- NCT00463333
- Acronym / sponsor ID
- 196/2004
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, psychometric testing, EEG, serum markers
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- May 2005
- First posted
- 20 Apr 2007 (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.
Summary:
Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients at Intensive Care Unit over a defined time period
- Over 18 years old
Key exclusion criteria (1 listed)
- Elective heart and vascular patients
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
Not reported in the source record.
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 20 Apr 2007.
- Derived from this study: PubMed 21037129Plaschke K, Kopitz J, Mattern J, Martin E, Teschendorf P. Increased cortisol levels and anticholinergic activity in cognitively unimpaired patients. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):433-41. doi: 10.1176/jnp.2010.22.4.433.
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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.
Markus A Weigand, PhD, MD principal investigator
Medical Faculty, Clinic of Anesthesiology, University of Heidelberg
Konstanze Plaschke, Prof. principal investigator
Clinic of Anesthesiology
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 Postoperative Delirium, 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 2 inclusion and 1 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 20 Apr 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463333, which also lists 1 linked publication.
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 20 Apr 2007.