Analysis of Medication Data With the ApoMining-Database

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528798
• Other study ID #: ApoMining
• Status: Completed
• Start date: October 22, 2014
• Est. completion date: September 25, 2017

Study information

• Verified date: May 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: September 25, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 91 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anticholinergic burden	Anticholinergic burden is calculated by the ApoMining-Database	One day before surgery
Other	Delirium prediction	Delirium prediction is calculated by Apomining database.	Up to the end of stay in the recovery room, an expected average of 1 day
Primary	Positive predictive value of postoperative delirium	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)	Up to 7 days after surgery
Secondary	Negative predictive value of postoperative delirium	Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium.	Up to 7 days after surgery
Secondary	Cholinesterase activity	Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study	Before surgery, one day after surgery, 3 months after surgery
Secondary	Delirium	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.	Up to 7 days after surgery