Neuroinflammation in sepsis encephalopathy: the NINEVEH-study

Neuroinflammation in sepsis encephalopathy: the NINEVEH-study - The NINVEH-study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003698-13-NL

Enrollment

Registered

2015-10-27

Start date

2015-12-30

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis MedDRA version: 18.1 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 100000004862

Interventions

Product Name: [18F]-DPA-714 Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: [18F]-pyrazolo[1,5-a]pyrimidine derivate CAS Number: 289-95-2 Current Sponsor code: BAY 85

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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 outcomes

Primary

Measure	Time frame
Main Objective: Measure in vivo neuroinflammation;Secondary Objective: neurocognitive outcomes;Primary end point(s): PET tracer uptake;Timepoint(s) of evaluation of this end point: 1-2 weeks after onset of sepsis	—

Secondary

Measure	Time frame
Secondary end point(s): neurocognitive outcomes;Timepoint(s) of evaluation of this end point: 3, 6, 12 months follow-up	—

Countries

Netherlands

Contacts

Public ContactDepartment of Intensive Care

Radboudumc

f.abdo@radboudumc.nl003124361727

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026