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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463333
Other study ID # 196/2004
Secondary ID
Status Completed
Phase N/A
First received September 10, 2005
Last updated April 19, 2007
Start date May 2005

Study information

Verified date April 2007
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients at Intensive Care Unit over a defined time period

- Over 18 years old

Exclusion Criteria:

- Elective heart and vascular patients

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Intensive Care Unit, Clinic of Anesthesiology Heidelberg

Sponsors (2)

Lead Sponsor Collaborator
Heidelberg University Else Kröner Fresenius Foundation

Country where clinical trial is conducted

Germany, 

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