Clinical trial NCT03528798: Analysis of Medication Data With the ApoMining-Database
Official title: Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 349
Sex: ALL
Minimum age (years): 65
Maximum age (years): 91
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients undergoing elective surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive predictive value of postoperative delirium
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Negative predictive value of postoperative delirium
timeFrame: Up to 7 days after surgery
measure: Cholinesterase activity
timeFrame: Before surgery, one day after surgery, 3 months after surgery
measure: Delirium
timeFrame: Up to 7 days after surgery
Other outcomes:
measure: Anticholinergic burden
timeFrame: One day before surgery
measure: Delirium prediction
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 day
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite - Universitätsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: