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
• 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
• 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

• Critical Illness
• Sepsis
• Sepsis Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

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