Septic Encephalopathy and Late Cognitive Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Verum

Group Type EXPERIMENTAL

n-3 fatty acids

Intervention Type DRUG

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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n-3 fatty acids

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No