Analysis of Medication Data With the ApoMining-Database

Completed

• Conditions: Delirium

• Registration Number: NCT03528798
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2014-10-22
• Primary Completion: 2017-05-05
• Study Completion: 2017-09-25
• Study First Submitted: 2018-04-24
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-18
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

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