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Septic Encephalopathy and Late Cognitive Dysfunction

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00772096
First received: October 14, 2008
Last updated: July 4, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Sepsis
Severe Sepsis
 Drug: n-3 fatty acids
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Delirium Sepsis
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Enrollment: 50
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum Drug: n-3 fatty acids
No Intervention: No treatment Drug: n-3 fatty acids

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772096

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Luzius A Steiner, MD, PhD Department of Anaesthesia, University Hospital Basel, Switzerland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00772096     History of Changes
Other Study ID Numbers: EK 151/08
Study First Received: October 14, 2008
Last Updated: July 4, 2011
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Sepsis
Toxemia
Cognition Disorders
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013