The overall objective of this study is to identify valid biomarkers for POD/POCD.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints: POCD rate at 3 month follow up.
Study determinants that are investigated include patient characteristics,
molecular and genetic biomakers determined from blood sampling, and
neuroimaging biomarkers.
Secondary outcome
Secondary endpoints are: POD rate during hospital admission, POCD rate at day 7
(or at the first testable day thereafter, or at the day of discharge), duration
and severity of POD, and severity of POCD at day 7 and at the 3 month follow
up. Further, we will study functional connectivity in delirium, hallucinations
without delirium, and a state without hallucinations and delirium in a
substudy.
Background summary
Cognitive impairment is increasingly prevalent in our society as a result of
aging and different, interacting medical conditions. An acute model of
cognitive impairment is postoperative cognitive dysfunction (POCD) which is
characterized by the progressive deterioration of cognitive function following
surgery with an incidence up to 20-50% early after the intervention,
particularly in elderly patients. An acute phase in cognitive dysfunction,
Postoperative Delirium (POD) may be followed by this more chronic POCD phase.
The socioeconomic implications of postoperative cognitive impairments are
profound: both POD and POCD are associated with longer hospital stay and
associated costs, increased mortality, and dependency on social transfer
payments. A better understanding of POD/POCD may serve as an inroad into our
understanding of multifactorial cognitive impairment and may facilitate the
development of novel treatments.
Study objective
The overall objective of this study is to identify valid biomarkers for
POD/POCD.
Study design
Prospective, multicenter, observational cohort study.
Study burden and risks
The burden to participate in this study is moderate and the risks associated
with study participation are low. Site visits will involve amongst others
neuroimaging and neuropsychological examinations. Furthermore, at several time
points blood samples will be drawn. The tests described in this protocol are
commonly used in clinical practices and/or research studies. Risks associated
with MRI procedures are minimal. An unforeseeable risk related to participation
in this study is the possible discovery of claustrophobia when entering the
small MRI scanning space which may be unknown to the subject. Subjects will be
able to terminate study participation at any time, for any reason. The acquired
knowledge from this study will enable the selection and integration of highly
sensitive neuroimaging, molecular and genetic biomarkers to guide treating
physicians in future patient care.
Augustenburger Platz 1
Berlin 13353
DE
Augustenburger Platz 1
Berlin 13353
DE
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02265263 |
| CCMO | NL50245.041.14 |