Primary objective is to assess in vivo neuroinflammation quantitatively in patients with sepsis. Secondary objective is to study whether differences in in vivo neuroinflammation are related to long term cognitive outcomes.
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PET-CT tracer uptake
Secondary outcome
Neuropsychological outcomes
Background summary
Following a hospitalization for an infection (e.g. sepsis), patients have
significantly increased risk for developing cognitive decline. In addition,
neuroinflammation plays an important role in the pathogenesis of
neurodegenerative disease. Systemic inflammation, as occurs during infections,
can induce neuroinflammation. It is hypothesized that neuroinflammation during
sepsis is an important factor to the trajectory of cognitive decline in
patients with sepsis.
Study objective
Primary objective is to assess in vivo neuroinflammation quantitatively in
patients with sepsis.
Secondary objective is to study whether differences in in vivo
neuroinflammation are related to long term cognitive outcomes.
Study design
Observational study
Study burden and risks
* Patients will undergo a single PET and MRI scan of the brain. The load of
ionizing radiation of the PET-CT is approximately 10 mSv; comparable to a
normal abdominal CT-scan. This will be performed 1-2 weeks after sepsis onset.
* One blood sampling will be performed to correct for individual affinity to
the PET tracer.
* Patient will undergo clinical examinations during the hospital admission,
including cognitive screening.
* At 3, 6 and 12 months, follow-up examination will be performed with the focus
on neuropsychological testing.
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Sepsis;
Age >50 years
Exclusion criteria
* Pregnancy or wish to become pregnant within 2 weeks after PET-CT scan;
* Contra-indication to undergo a CT or MRI scan, including claustrophobia;
* Unstable hemodynamics or respiration that contra-indicate transport and undergoing PET/MRI imaging;
* Other causes not related to sepsis that sufficiently explain (relation in time) the onset of delirium such as newly onset severe kidney or liver failure, or severe electrolyte disturbances, severe hypoglycaemia;
* Delirium coinciding with start of medications known to increase the risk of development of delirium. This will be judged by the delirium expert: e.g. neurologist, geriatrician, or senior delirium researcher (e.g. based on the type of drug known to trigger delirium and the temporal relationship between start of the medication and onset of delirium);
* Presence of delirium before onset of infection;
* Age < 50 years;
* Moribund patients or patients on palliative care;
* Brain or spinal surgery within the last 3 months;
* Meningitis or brain infection within the 6 months;
* Pre-existing cognitive impairment interfering with the ability to understand informational material about this research project;
* Presence of a CSF catheter or shunt;
* Patients with known brain tumours;
* Patients with brain injury (e.g. acute stroke, brain trauma, or subarachnoid haemorrhage) within the last 3 months;
* Chronic (>6 weeks) use of immunosuppressive agents;
* Concomitant diseases resulting in severe immunosuppression (e.g. HIV);
* Chronic use of neuroleptics, defined as pre-hospital use;
* Patients that do not speak Dutch or have disabilities that prevent accurate delirium diagnosis;
* Analphabetic patients;
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2015-003698-13-NL |
| CCMO | NL54775.091.15 |