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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

September 8, 2006

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00142220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Sepsis Syndrome

Intervention ^†

Drug: Defined percentage of omega-3-fatty acids

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

160

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

indication for parenteral nutrition

Exclusion Criteria:

hypertriglyceridemia
coagulation disorder
decompensated liver cirrhosis or acute liver failure

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00142220

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Ernst Moritz Arndt University of Greifswald

Collaborators ^††

Fresenius AG

Investigators ^†

Principal Investigator:

Sigrun Friesecke, Dr.

Ernst Moritz Arndt University of Greifswald

Information Provided By

Ernst Moritz Arndt University of Greifswald

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.