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Biomarker Development for Postoperative Cognitive Impairment in the Elderly

Completed
Conditions
confusion
memory deficits
10012221
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
<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
NameTimeMethod
<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>
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