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Acetylcholinesterase in Postoperative Delirium

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT02315846
Collaborator
(none)
120
Enrollment
1
Location
5.9
Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. change of acetylcholinesterase (U/l) [one day before surgery, 1-24h after surgery, 25-72h after surgery]

      change of acetylcholinesterase in units per litre

    Secondary Outcome Measures

    1. change of NuDESC [one day before surgery, 1-24h after surgery, 25-72h after surgery]

      change of nursing delirium screening score

    2. change of medication [one day before surgery, 1-24h after surgery, 25-72h after surgery]

      change of medication, that could influence a delirium

    3. ICD-codes of main disease [25-72h after surgery]

      International classification of diseases-code of main disease

    4. ICD-codes of coexisting diseases [25-72h after surgery]

      International classification of diseases-codes of coexisting diseases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed written informed consent

    • Elective surgery

    Exclusion Criteria:

    • Preexisting psychiatric or neurological disease

    • No surgery

    • Reduced level of consciousness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Heidelberg Heidelberg Germany 69120

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Study Director: Konstanze Plaschke, PhD, Heidelberg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christoph Schramm, M.D., Principal Investigator, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT02315846
    Other Study ID Numbers:
    • S452/2013
    First Posted:
    Dec 12, 2014
    Last Update Posted:
    May 17, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of May 17, 2018