Septic Encephalopathy and Late Cognitive Dysfunction
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| ClinicalTrials.gov Identifier: NCT00772096 |
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Recruitment Status
:
Completed
First Posted
: October 15, 2008
Last Update Posted
: March 10, 2015
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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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Verum | Drug: n-3 fatty acids |
| No Intervention: No treatment |
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00772096
| Switzerland | |
| University Hospital Basel | |
| Basel, Switzerland, 4031 | |
| Principal Investigator: | Luzius A Steiner, MD, PhD | Department of Anaesthesia, University Hospital Basel, Switzerland |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov 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:
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Sepsis Toxemia Brain Diseases Cognitive Dysfunction Sepsis-Associated Encephalopathy Infection Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Central Nervous System Diseases Nervous System Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders |