Septic Encephalopathy and Late Cognitive Dysfunction
Primary Purpose
Sepsis, Severe Sepsis
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
n-3 fatty acids
Sponsored by
About this trial
This is an interventional prevention trial for Sepsis
Eligibility 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
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Verum
No treatment
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00772096
First Posted
October 14, 2008
Last Updated
March 9, 2015
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00772096
Brief Title
Septic Encephalopathy and Late Cognitive Dysfunction
Official Title
Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum
Arm Type
Experimental
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
n-3 fatty acids
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luzius A Steiner, MD, PhD
Organizational Affiliation
Department of Anaesthesia, University Hospital Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24660837
Citation
Burkhart CS, Dell-Kuster S, Siegemund M, Pargger H, Marsch S, Strebel SP, Steiner LA. Effect of n-3 fatty acids on markers of brain injury and incidence of sepsis-associated delirium in septic patients. Acta Anaesthesiol Scand. 2014 Jul;58(6):689-700. doi: 10.1111/aas.12313. Epub 2014 Mar 24.
Results Reference
derived
Learn more about this trial
Septic Encephalopathy and Late Cognitive Dysfunction
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