DeliriumNCT03528798
Analysis of Medication Data With the ApoMining-Database
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 65 to 91 years
- Conditions the study is for
- Delirium
- How many people
- 349 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2014to 25 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 91 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing elective surgery
Who may be able to join
- From BioCog study (NCT02265263)
- Enrollment at Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
Who cannot join
- From BioCog study (NCT02265263)
- Additionally for this analysis:
- No delirium assessment
- No long-term medication before operation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
Official title: Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
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).
Read the 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.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 7 days after surgery
Secondary outcomes (3)
Negative predictive value of postoperative delirium
Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium.
Measured: Up to 7 days after surgery
Cholinesterase activity
Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study
Measured: Before surgery, one day after surgery, 3 months after surgery
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.
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start22 Oct 2014
- Primary completion5 May 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528798
- Sponsor's protocol ID
- ApoMining
- Status last verified
- May 2018
- First submitted
- 24 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study
- ClinicalTrials.gov ID
- NCT03528798
- Acronym / sponsor ID
- ApoMining
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing elective surgery
Key inclusion criteria (2 listed)
- From BioCog study (NCT02265263)
- Enrollment at Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
Key exclusion criteria (4 listed)
- From BioCog study (NCT02265263)
- No delirium assessment
- No long-term medication before operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Negative predictive value of postoperative delirium
Time frame: Up to 7 days after surgery
Cholinesterase activity
Time frame: Before surgery, one day after surgery, 3 months after surgery
Delirium
Time frame: Up to 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
Related trials for Delirium
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Active, not recruiting
TaVNS for Delirium
Delirium
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of postoperative delirium (time frame: Up to 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.