NCT00463333

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 10, 2005

Last Update Submit

April 19, 2007

Conditions

Postoperative Delirium

Keywords

postoperative deliriumpsychometric testingEEGserum markers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients at Intensive Care Unit over a defined time period
  • Over 18 years old

You may not qualify if:

  • Elective heart and vascular patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Clinic of Anesthesiology

Heidelberg, Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21037129DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Markus A Weigand, PhD, MD

    Medical Faculty, Clinic of Anesthesiology, University of Heidelberg

    PRINCIPAL INVESTIGATOR

  • Konstanze Plaschke, Prof.

    Clinic of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

April 20, 2007

Study Start

May 1, 2005

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

DE(1)