Septic Encephalopathy and Late Cognitive Dysfunction

Phase 4

Completed

• Conditions: Sepsis; Severe Sepsis
• Interventions: Drug: n-3 fatty acids

• Registration Number: NCT00772096
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	n-3 fatty acids	-

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland