Septic Encephalopathy and Late Cognitive Dysfunction

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Severe Sepsis; Sepsis

Treatments: Drug: n-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT00772096

EK 151/08

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Verum

Experimental group

Treatment:

Drug: n-3 fatty acids

No treatment

No Intervention group