Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
NCT Number: NCT03528798
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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Notify Me65 year–91 year
All sexes
Observational
Berlin, 13353, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additionally for this analysis:
Inclusion criteria
Exclusion criteria
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)
Time frame: Up to 7 days after surgery
Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium.
Time frame: Before surgery, one day after surgery, 3 months after surgery
Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study
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.
Time frame: One day before surgery
Anticholinergic burden is calculated by the ApoMining-Database
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.
Charite University, Berlin, Germany
Other
Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
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