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The Effects of Eicosapentaenoic Acid (EPA), Gamma-Linolenic Acid (GLA) and Antioxidants in the Treatment of Sepsis

NCT00329680 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2009-12-31

No results posted yet for this study

Summary

The scope of this clinical study is to evaluate the possible role of an enteral formulation enriched with EPA, GLA and Antioxidants in patients diagnosed in the early stages of sepsis despite mechanical ventilation requirements, as well as the impact of this diet upon glycemic control and its capacity to prevent the development of sepsis into severe sepsis and septic shock.

Conditions

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Interventions

DIETARY_SUPPLEMENT

Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins

An enteral diet will be given in accordance with the caloric goal calculated by the Harris-Benedict equation x 1.3. The enteral diet will be provided for a period of 7 days or until death OR start of oral diet OR start of parenteral diet OR discharge from the ICU OR decision from the attending physician/family/patient to no longer participate in this clinical study

DIETARY_SUPPLEMENT

Standard ICU enteral diet, isocaloric to the study diet

Patients will receive this diet in a blinded way using the same dose regimen specified previously and used in the study group

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Fernandes Tavora Hospital

    lead OTHER

Principal Investigators

  • Alessandro Pontes-Arruda, MD, PhD · Hospital Fernandes Távora

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-12-31
Completion
2009-10-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329680 on ClinicalTrials.gov