Biomarker Development for Postoperative Cognitive Impairment in the Elderly
- Conditions
- confusionmemory deficits10012221
- Registration Number
- NL-OMON44903
- Lead Sponsor
- Charite Berlijn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
1. Male and female participants aged 65 years or older,
2. Ability to give informed consent after verbal and written information,
3. European ancestry (up till grandparents) for homogeneity reasons for the molecular and genetic investigations.
Patients also need to meet the following criteria:
4. Undergoing elective surgery,
5. Planned operation time > 60 minutes.
1. MMSE score * 23,
2. Planned intracranial operation,
3. Any medical (e.g., vision or hearing) or (neuro)psychiatric condition that would make neuropsychological and/or neuroimaging testing impossible,
4. Claustrophobia or other reasons (e.g., large tattoos) that make the participant unsuitable to undergo MRI investigations,
5. Homelessness or other circumstances where the patient would not be reachable by phone or postal services during follow-up,
6. Participation in an intervention study during study participation,
7. Admission under judicial or official orders,
8. Life expectancy less than 1 year,
9. Withdrawal of informed consent to store, use and distribute pseudomized data which will be gathered during the clinical study period.
Control participants additionally will be excluded if the following criterion applies:
10. Elective or emergency surgery during the study period.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints: POCD rate at 3 month follow up.<br /><br>Study determinants that are investigated include patient characteristics,<br /><br>molecular and genetic biomakers determined from blood sampling, and<br /><br>neuroimaging biomarkers. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are: POD rate during hospital admission, POCD rate at day 7<br /><br>(or at the first testable day thereafter, or at the day of discharge), duration<br /><br>and severity of POD, and severity of POCD at day 7 and at the 3 month follow<br /><br>up. Further, we will study functional connectivity in delirium, hallucinations<br /><br>without delirium, and a state without hallucinations and delirium in a<br /><br>substudy.</p><br>