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

Primary Purpose

Sepsis Syndrome

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Defined percentage of omega-3-fatty acids
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis Syndrome

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: indication for parenteral nutrition Exclusion Criteria: hypertriglyceridemia coagulation disorder decompensated liver cirrhosis or acute liver failure

Sites / Locations

  • Internistische ITS

Outcomes

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

Full Information

First Posted
August 31, 2005
Last Updated
September 8, 2006
Sponsor
University Medicine Greifswald
Collaborators
Fresenius AG
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1. Study Identification

Unique Protocol Identification Number
NCT00142220
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald
Collaborators
Fresenius AG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Defined percentage of omega-3-fatty acids
Primary Outcome Measure Information:
Title
level of IL-6 in serum
Title
HLA-expression on monocytes
Secondary Outcome Measure Information:
Title
number of nosocomial infections
Title
days on mechanical ventilation
Title
duration of ICU stay
Title
mortality
Title
SOFA score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indication for parenteral nutrition Exclusion Criteria: hypertriglyceridemia coagulation disorder decompensated liver cirrhosis or acute liver failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigrun Friesecke, Dr.
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internistische ITS
City
Greifswald
ZIP/Postal Code
17475
Country
Germany

12. IPD Sharing Statement

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

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