To assess in vivo microglial activation (as a validated marker of neuroinflammation) using PET-CT and associated neuropsychological characteristics in patients recovered from sepsis associated delirium.
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Cerebral PK11195 binding potential (BP).
2) Test-score on different neuropsychological domains.
Secondary outcome
1) Duration of delirium.
2) DRS-R-98.
3) MMSE.
Background summary
Delirium is a highly frequent complication developing in a wide array of
medical conditions. In critically-ill elderly patients admitted to the ICU,
estimations of occurrence rates are as high as 80%. The long-term health
consequences associated with delirium are becoming increasingly appreciated in
recent years. Meta-analysis has shown a significantly higher risk of dementia,
institutionalization and death in the years following delirium. Although
research in post-delirium patients is scarce, various findings suggest the
pathophysiological importance of prolonged neuroinflammation due to cholinergic
deficiency.
Study objective
To assess in vivo microglial activation (as a validated marker of
neuroinflammation) using PET-CT and associated neuropsychological
characteristics in patients recovered from sepsis associated delirium.
Study design
Observational, cross-sectional, case-control study.
Study burden and risks
The only risk related to participating in this study for both cases and
controls is that MRI might reveal unexpected findings. Whenever this would
occur, patients will be informed by one of the principle investigators and will
be offered consultation at the outpatient clinic of the Department of Neurology
of the AMC. No further risks are related to the other procedures, including
PET-CT imaging. Effective dose equivalents are specified in the *Radiation
burden*-form, which will be separately admitted for approval to the Department
of Radiology.
The only extra burden related to participating in this study is that patients
have to travel to the AMC and VUmc after discharge to undergo MRI, PET-CT and
neuropsychological evaluation. Completion of the studyprocedures is estimate to
take 6 hours in total.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Cases/controls: 1) age >65 jaar
Cases: 2) Clinical diagnosis of delirium during hospital admission, 3) Development of sepsis <14 days prior to delirium, 4) Clinical recovery from delirium at discharge.
Exclusion criteria
1) Diagnosis of dementia or other major central nervous system pathology or psychiatric disease; 2) Previous episode of delirium; 3) Indication of prior cognitive impairment; 4) History of alcohol/substance abuse or severe headtrauma.
Cases: 5) Physical disability at discharge necessitating discharge to a nursing facility
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 |
|---|---|
| CCMO | NL37129.018.11 |