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

This study has been completed.

Sponsor:

Collaborator:

Fresenius AG

Information provided by:

University Medicine Greifswald

ClinicalTrials.gov Identifier:

NCT00142220

First received: August 31, 2005

Last updated: September 8, 2006

Last verified: September 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

September 8, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

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

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Sepsis Syndrome

Intervention ^ICMJE

Drug: Defined percentage of omega-3-fatty acids

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

indication for parenteral nutrition

Exclusion Criteria:

hypertriglyceridemia
coagulation disorder
decompensated liver cirrhosis or acute liver failure

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00142220

Other Study ID Numbers ^ICMJE

OMEGAVEN

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Medicine Greifswald

Collaborators ^ICMJE

Fresenius AG

Investigators ^ICMJE

Principal Investigator:

Sigrun Friesecke, Dr.

University Medicine Greifswald

Information Provided By

University Medicine Greifswald

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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