Delirium Clinical Trial
Official title:
Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
Verified date | May 2018 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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 |
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