euroinflammation in sepsis encephalopathy: the NINEVEH-study

Completed

• Conditions: 10014623; 'sepsis associated delirium'; post-sepsis syndrome; 10002252

• Registration Number: NL-OMON42342
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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;

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PET-CT tracer uptake</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neuropsychological outcomes</p><br>