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

NCT00329680 | Completed Phase 4 DMC

• 1 other identifier: ILAS-04-ABT
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 12

Brief 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

Keywords

Sepsis; Severe Sepsis; Septic Shock; Enteral Nutrition; Antioxidants; EPA; GLA; Nutrition; Intensive Care; ICU

Outcome Measures

Primary Outcomes (1)

• Evolution to more severe forms of the disease

  28-days follow up

Secondary Outcomes (1)

• 28 days all-cause mortality,hyperglycemia, hypoglycemia, mean dose of insulin, use of hospital resources, ICU-free days,creatinine clearance, development of new organ failure,Evolution of the SOFA

  28-days follow up

Study Arms (2)

1

EXPERIMENTAL

Experimental arm will receive an enteral diet enriched with EPA, GLA and Antioxidant vitamins

Dietary Supplement: Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins

2

PLACEBO COMPARATOR

This arm will receive an enteral diet considered as a "standard" ICU diet, isocaloric to the control diet but not enhanced with EPA, GLA and antioxidant vitamins

Dietary Supplement: Standard ICU enteral diet, isocaloric to the study diet

Interventions

Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins DIETARY_SUPPLEMENT

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

Also known as: Oxepa (Ross Products Division, Abbott Laboratories)

1

Standard ICU enteral diet, isocaloric to the study diet DIETARY_SUPPLEMENT

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

Also known as: Osmolite HiCal/Ensure Pkus HN (Ross Products Division, Abbott Laboratories)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age, at the intensive care unit with diagnosis of sepsis and requiring enteral nutrition
• The diagnosis of sepsis follow the criteria previously defined by Bone et al., and modified in accordance with Bernard GR et al
• In addition, patients MUST achieve at least once 75% of BEE (calculated using the Harris-Benedict equation) x 1.3 to be considered evaluable
• Patient septic state and caloric intake will be accessed in a daily basis

You may not qualify if:

• Patients with septic shock at the baseline
• Pregnancy or breastfeeding
• Patients under 18 years of age
• Significant limitation of survival prognosis (patients expecting a life survival under 28 days due to a chronic and/or incurable disease such as uncontrolled cancer or other terminal disease)
• Pre-existing chronic renal insufficiency and need of hemodialysis or peritoneal dialysis
• Acute pancreatitis without established origin
• Head trauma with a Glasgow Come Score (GCS) less or equal to 5
• Recent stroke or subarachnoid hemorrhage (less than 3 months)
• Severe immunologic suppression (defined as a leukocyte count bellow 5.000 cells/mm3)
• Infection by the human immunodeficiency virus
• Patients with no indication for enteral feeding or in the imminence of receiving parenteral nutrition
• Patients receiving partial parenteral nutrition in order to achieve caloric goal
• Presence of uncontrolled diarrhea
• Recent gastrointestinal bleeding event
• Patient's, patient's legal representative or physicians decision to exclude patients from this protocol, known hypertriglyceridemia, obesity with BMI over 29.9.

Sponsors & Collaborators

• Fernandes Tavora Hospital: lead
• Abbott: collaborator

Study Sites (12)

Hospital Fernandes Távora - Adult Intensive Care Unit

Fortaleza, Ceará, 60.115-000, Brazil

Location

Hospital Português - Real Sociedade Portuguesa 16 de Setembro

Salvador, Estado de Bahia, 40.130-030, Brazil

Location

Hospital Salvador

Salvador, Estado de Bahia, 40.130-030, Brazil

Location

Hospital Santa Luzia

Brasília, Federal District, Brazil

Location

Hospital de Clínicas da Universidade Federal da Paraíba

João Pessoa, Paraíba, 60000000, Brazil

Location

Clínica São Vicente

Rio de Janeiro, Rio de Janeiro, 21000000, Brazil

Location

Hospital Pró-Cardíaco

Rio de Janeiro, Rio de Janeiro, 21000000, Brazil

Location

Associação Beneficente Evangélica de Joinville - Hospital Dona Helena

Joinville, Santa Catarina, 89.204-050, Brazil

Location

Centro Hospitalar Unimed

Joinville, Santa Catarina, 89.204-060, Brazil

Location

Fundação Faculdade de Medicina de São José Do Rio Preto

São José do Rio Preto, São Paulo, 15.090-000, Brazil

Location

Hospital São Paulo-UNIFESP

São Paulo, São Paulo, 04.024-900, Brazil

Location

Instituto de Assistência Médica Ao Servidor Público Estadual-Iamspe

São Paulo, São Paulo, 04.039-901, Brazil

Location

Related Links

• Latin American Sepsis Institute Homepage

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Eicosapentaenoic Acid; gamma-Linolenic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Linolenic Acids; Fatty Acids, Essential; Fatty Acids, Omega-6

Study Officials

• Alessandro Pontes-Arruda, MD, PhD

  Hospital Fernandes Távora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: December 31, 2009

Record last verified: 2009-10

Locations

BR (12)