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NCT00772096 Clinical Trial

Septic Encephalopathy and Late Cognitive Dysfunction

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00772096
Other study ID # EK 151/08
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2008
Last updated March 9, 2015
Start date October 2008
Est. completion date June 2011

Study information
Verified date March 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• n-3 fatty acids

Locations
Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

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