NCT00142220

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

August 31, 2005

Last Update Submit

September 8, 2006

Conditions

Sepsis Syndrome

Outcome Measures

Primary Outcomes (2)

  • level of IL-6 in serum

  • HLA-expression on monocytes

Secondary Outcomes (5)

  • number of nosocomial infections

  • days on mechanical ventilation

  • duration of ICU stay

  • mortality

  • SOFA score

Interventions

Defined percentage of omega-3-fatty acidsDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • indication for parenteral nutrition

You may not qualify if:

  • hypertriglyceridemia
  • coagulation disorder
  • decompensated liver cirrhosis or acute liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internistische ITS

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Sigrun Friesecke, Dr.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

January 1, 2004

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

DE(1)