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NCT00142220 Clinical Trial

The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients

Sepsis Syndrome Clinical Trial

Official title:
Comparison Between Two Different Proportions of Omega-3- and Omega-6-Fatty Acids in the Parenteral Nutrition of Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00142220
Other study ID # OMEGAVEN
Secondary ID
Status Completed
Phase Phase 4
First received August 31, 2005
Last updated September 8, 2006
Start date January 2004

Study information
Verified date September 2006
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in the nutrition of critically ill patients reduces systemic inflammation.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- indication for parenteral nutrition

Exclusion Criteria:

- hypertriglyceridemia

- coagulation disorder

- decompensated liver cirrhosis or acute liver failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Defined percentage of omega-3-fatty acids

Locations
Country Name City State
Germany Internistische ITS Greifswald

Sponsors (2)
Lead Sponsor Collaborator
University Medicine Greifswald Fresenius AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary level of IL-6 in serum
Primary HLA-expression on monocytes
Secondary number of nosocomial infections
Secondary days on mechanical ventilation
Secondary duration of ICU stay
Secondary mortality
Secondary SOFA score
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