Delirium
Conditions
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).
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 91 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cholinesterase activity | Before surgery, one day after surgery, 3 months after surgery | Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Anticholinergic burden | One day before surgery | Anticholinergic burden is calculated by the ApoMining-Database |
| 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. |
Countries
Germany
Outcome results
None listed