euroinflammation in sepsis encephalopathy: the NINEVEH-study

• Conditions: sepsis; MedDRA version: 18.1Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003698-13-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-27
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Sepsis
Age>50 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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: Interventional clinical trial of medicinal product
• Study Design: Not specified