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

This study has been completed.

Sponsors and Collaborators:	Ernst Moritz Arndt University of Greifswald Fresenius AG
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00142220

Purpose

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.

Condition	Intervention	Phase
Sepsis Syndrome	Drug: Defined percentage of omega-3-fatty acids	Phase IV

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison Between Two Different Proportions of Omega-3- and Omega-6-Fatty Acids in the Parenteral Nutrition of Critically Ill Patients

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:

level of IL-6 in serum
HLA-expression on monocytes

Secondary Outcome Measures:

number of nosocomial infections
days on mechanical ventilation
duration of ICU stay
mortality
SOFA score

Estimated Enrollment:	160
Study Start Date:	January 2004

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

indication for parenteral nutrition

Exclusion Criteria:

hypertriglyceridemia
coagulation disorder
decompensated liver cirrhosis or acute liver failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142220

Locations

Germany
Internistische ITS
Greifswald, Germany, 17475

Sponsors and Collaborators

Ernst Moritz Arndt University of Greifswald

Fresenius AG

Investigators

Principal Investigator:

Sigrun Friesecke, Dr.

Ernst Moritz Arndt University of Greifswald

More Information

Study ID Numbers:	OMEGAVEN
Study First Received:	August 31, 2005
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00142220
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Critical Illness
Inflammation

Additional relevant MeSH terms:

Disease Attributes
Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009