NCT03528798

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

April 24, 2018

Last Update Submit

May 17, 2018

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Negative predictive value of postoperative delirium

    Up to 7 days after surgery

  • Cholinesterase activity

    Before surgery, one day after surgery, 3 months after surgery

  • Delirium

    Up to 7 days after surgery

Other Outcomes (2)

  • Anticholinergic burden

    One day before surgery

  • Delirium prediction

    Up to the end of stay in the recovery room, an expected average of 1 day

Eligibility Criteria

Age65 Years - 91 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients undergoing elective surgery

You may qualify if:

  • From BioCog study (NCT02265263)

You may not qualify if:

  • From BioCog study (NCT02265263)
  • Additionally for this analysis:
  • Enrollment at Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
  • No delirium assessment
  • No long-term medication before operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Claudia Spies, MD, Prof.

    Charite - Universitätsmedizin Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK)

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 18, 2018

Study Start

October 22, 2014

Primary Completion

May 5, 2017

Study Completion

September 25, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)