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Analysis of Medication Data With the ApoMining-Database

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT03528798
Collaborator
(none)
349
Enrollment
1
Location
35.1
Actual Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to analyse medication data from the BioCog Study with the ApoMining-Database and to determine the positive and negative predictive value from the ApoMining-Database for prediction of postoperative delirium (POD).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    From 2014-2017 the BioCog Study (ClinicalTrials.gov Identifier: NCT02265263) collected data from 439 perioperative elderly patients in Campus Virchow - Klinikum, Universitätsmedizin Berlin. According to the study protocol, a delirium assessment was performed each day after operation until the 7th postoperative day. At this time, it is known which patients developed postoperative delirium (POD) and which did not. Additionally, from each patient data on long-term medication before operation and applied medication during operation and in the recovery room were collected. In this study, the investiagtors analyse the long-term medication and the perioperative medication from BioCog-Study patients with the ApoMining-Database (http://www.apothesen.de/index.php?id=878; ApoThesenGmbH; Bad Münstereifel; Germany). The ApoMining-Database is a medication database, which analyse tolerability and risks of medications for the elderly. The database generates a hit once a medication reveal a risk for delirium. Additionally, the database can calculate the anticholinergic burden of the medication according to the prescribing information. Whereas the investigators already know, which patient developed a POD, they will determine positive and negative predictive value from the ApoMining-Database for prediction of postoperative delirium.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    349 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
    Actual Study Start Date :
    Oct 22, 2014
    Actual Primary Completion Date :
    May 5, 2017
    Actual Study Completion Date :
    Sep 25, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Positive predictive value of postoperative delirium [Up to 7 days after surgery]

      Positive predictive value of the application of the ApoMining-Database for prediction of postoperative Delirium (the prediction of delirium by Apomining data base compared to occurence of Delirium in BioCog study)

    Secondary Outcome Measures

    1. Negative predictive value of postoperative delirium [Up to 7 days after surgery]

      Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium.

    2. Cholinesterase activity [Before surgery, one day after surgery, 3 months after surgery]

      Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study

    3. Delirium [Up to 7 days after surgery]

      Delirium is defined within the BioCog study: according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and/or as ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method (CAM) and/or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score and/or patient chart review that shows descriptions of delirium.

    Other Outcome Measures

    1. Anticholinergic burden [One day before surgery]

      Anticholinergic burden is calculated by the ApoMining-Database

    2. Delirium prediction [Up to the end of stay in the recovery room, an expected average of 1 day]

      Delirium prediction is calculated by Apomining database.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 91 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • From BioCog study (NCT02265263)
    Exclusion Criteria:
    • From BioCog study (NCT02265263)
    Additionally for this analysis:
    Inclusion criteria:

    • Enrollment at Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin

    Exclusion criteria:

    • No delirium assessment

    • No long-term medication before operation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Charite - Universitätsmedizin Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03528798
    Other Study ID Numbers:
    • ApoMining
    First Posted:
    May 18, 2018
    Last Update Posted:
    May 18, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of May 18, 2018