Septic Encephalopathy and Late Cognitive Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772096
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sepsis Severe Sepsis Drug: n-3 fatty acids Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation
Study Start Date : October 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Verum Drug: n-3 fatty acids
No Intervention: No treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772096

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00772096     History of Changes
Other Study ID Numbers: EK 151/08
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Brain Diseases
Cognitive Dysfunction
Sepsis-Associated Encephalopathy
Systemic Inflammatory Response Syndrome
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders