Septic Encephalopathy and Late Cognitive Dysfunction

Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00772096

Enrollment

Registered

2008-10-15

Start date

2008-10-31

Completion date

2011-06-30

Last updated

2015-03-10

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

Conditions

Sepsis, Severe Sepsis

Brief summary

Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction. Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.

Interventions

DRUGn-3 fatty acids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock * Age 18 or older

Exclusion criteria

* Primary infection of the CNS * History of cerebrovascular disease * History of any neoplasia involving the CNS * History of long-term psychiatric medication * History of allergy to fish- or egg-protein * Severe coagulation abnormalities * Clinical signs of altered coagulation, active bleeding * Pregnancy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026