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Septic Encephalopathy and Late Cognitive Dysfunction

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00772096
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
32
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: n-3 fatty acids
 Phase 4

Study Design

Study Type:
Interventional
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 :
Oct 1, 2008
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Verum

Drug: n-3 fatty acids
No Intervention: No treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT00772096
    Other Study ID Numbers:
    • EK 151/08
    First Posted:
    Oct 15, 2008
    Last Update Posted:
    Mar 10, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Brain Diseases
    Sepsis-Associated Encephalopathy
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Mar 10, 2015