Status:
TERMINATED
Fish OIL Optimal dosE Determination Study
Lead Sponsor:
University Hospital Carl Gustav Carus
Collaborating Sponsors:
University of Giessen
Clinical Evaluation Research Unit at Kingston General Hospital
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this trial is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis ...
Detailed Description
Objectives: The overall objective is to determine the effect of IV fish oil on 28-day mortality of critically ill patients with severe sepsis. However, prior to such a large trial, we need to determin...
Eligibility Criteria
Inclusion
- Adult ICU patients
- Requiring invasive or non-invasive ventilation
- Clinical evidence of sepsis
- Presence of one or more organ failures
Exclusion
- \>24 hours from admission to ICU to time of consent
- Low level of inflammatory cytokine (IL-6(qualitative assay \<100 pg/ml)
- lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
- Immunocompromised (post-organ transplantation, HIV, neutropenic \[\<1000 PMN\], steroids \>20 mgs/day for 6 months).
- Chronic non-invasive ventilation (except if they become mechanically ventilated)
- Platelet count of \< 30 GPt/L
- Pregnant patients. Urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice.
- Previous enrollment in this study
- Enrollment in other ICU intervention study
- Allergy to fish or fish oil (shellfish allergy not an exclusion criterion)
- Has already received enteral or IV omega-3 fatty acids during this hospitalization and current ICU admission.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01146821
Start Date
October 1 2013
End Date
April 1 2017
Last Update
April 19 2017
Active Locations (2)
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1
University Hospital Dresden
Dresden, Germany, D-01307
2
University Hospital Giessen and Marburg
Giessen, Germany, D-35392