Septic Encephalopathy and Late Cognitive Dysfunction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00772096

First received: October 14, 2008

Last updated: March 9, 2015

Last verified: March 2015

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: Brain Diseases 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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00772096 History of Changes
Other Study ID Numbers:	EK 151/08
Study First Received:	October 14, 2008
Last Updated:	March 9, 2015
Health Authority:	Switzerland: Ethikkommission

Additional relevant MeSH terms:


Sepsis Toxemia Brain Diseases Sepsis-Associated Encephalopathy Infection	Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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