Status:
TERMINATED
Biomarker Development for Postoperative Cognitive Impairment in the Elderly (BioCog)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
European Union
Conditions:
Postoperative Delirium (POD)
Postoperative Cognitive Deficit (POCD)
Eligibility:
All Genders
65+ years
Brief Summary
The research leading consortium to these results has received funding from the European Union Seventh Framework Programme \[FP7/2007-2013\] under grant agreement no 602461 (www.biocog.eu). The invest...
Eligibility Criteria
Inclusion
- Study Group (Berlin/Utrecht):
- Male and female patients aged ≥ 65 years, of European descent (Caucasian)
- Elective surgery with an expected operative time ≥ 60 minutes
- Ability to give informed consent after receiving spoken and written information of the study
- Eligibility for magnetic resonance Imaging
Exclusion
- Mini-Mental-State-Examination ≤ 23 points
- Homelessness or other circumstances where the patient would not be reachable by phone or postal services during follow-up.
- Participation in another prospective interventional clinical study during participation in this clinical study during hospital stay
- Accommodation in an institution due to an official or judicial order
- Missing informed consent for saving and hand out pseudonymous data
- Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
- Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
- Intraoperative clectroencephalography - examinations (Study Group Berlin):
- Exclusion criteria:
- Neurological preconditions
- Proposed neurological surgery
- Control Group (Berlin/Utrecht):
- Inclusion criteria:
- Male and female patients aged ≥ 65 years, of European descent (Caucasian)
- ASA II and III patients
- No operation in the last half year before study inclusion
- Eligibility for magnetic resonance Imaging
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
1054 Patients enrolled
Trial Details
Trial ID
NCT02265263
Start Date
October 1 2014
End Date
June 1 2019
Last Update
September 25 2019
Active Locations (2)
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1
Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
2
Department of Intensive Care Medicine, University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX