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Analysis of Medication Data With the ApoMining-Database

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ClinicalTrials.gov Identifier: NCT03528798
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, 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).

Condition or disease
Delirium

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.

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Study Type : Observational
Actual Enrollment : 349 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
Actual Study Start Date : October 22, 2014
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Positive predictive value of postoperative delirium [ Time Frame: 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 :
  1. Negative predictive value of postoperative delirium [ Time Frame: Up to 7 days after surgery ]
    Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium.

  2. Cholinesterase activity [ Time Frame: Before surgery, one day after surgery, 3 months after surgery ]
    Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study

  3. Delirium [ Time Frame: 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 Outcome Measures:
  1. Anticholinergic burden [ Time Frame: One day before surgery ]
    Anticholinergic burden is calculated by the ApoMining-Database

  2. Delirium prediction [ Time Frame: Up to the end of stay in the recovery room, an expected average of 1 day ]
    Delirium prediction is calculated by Apomining database.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 91 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients undergoing elective surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528798


Locations
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Germany
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Director: Claudia Spies, MD, Prof. Charite - Universitätsmedizin Berlin
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Responsible Party: Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03528798    
Other Study ID Numbers: ApoMining
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders