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Completed

NCT Number: NCT03528798

Analysis of Medication Data With the ApoMining-Database

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).

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Key information

Age range

65 year–91 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Positive predictive value of postoperative delirium

    Time frame: 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 outcomes

  1. Negative predictive value of postoperative delirium

    Time frame: Up to 7 days after surgery

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

  2. Cholinesterase activity

    Time frame: Before surgery, one day after surgery, 3 months after surgery

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

  3. Delirium

    Time frame: 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 outcomes

  1. Anticholinergic burden

    Time frame: One day before surgery

    Anticholinergic burden is calculated by the ApoMining-Database

  2. Delirium prediction

    Time frame: Up to the end of stay in the recovery room, an expected average of 1 day

    Delirium prediction is calculated by Apomining database.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 18, 2018
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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