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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Fernandes Tavora Hospital
ClinicalTrials.gov Identifier:
NCT00329680
First received: May 23, 2006
Last updated: December 30, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Sepsis
Severe Sepsis
Septic Shock
Dietary Supplement: Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins
Dietary Supplement: Standard ICU enteral diet, isocaloric to the study diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Nutritional Therapy With EPA, GLA and Antioxidants Role in Sepsis Treatment-INTERSEPT STUDY

Resource links provided by NLM:


Further study details as provided by Fernandes Tavora Hospital:

Primary Outcome Measures:
  • Evolution to more severe forms of the disease [ Time Frame: 28-days follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 28-days follow up ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: June 2007
Study Completion Date: October 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental arm will receive an enteral diet enriched with EPA, GLA and Antioxidant vitamins
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
Other Name: Oxepa (Ross Products Division, Abbott Laboratories)
Placebo Comparator: 2
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
Patients will receive this diet in a blinded way using the same dose regimen specified previously and used in the study group
Other Name: Osmolite HiCal/Ensure Pkus HN (Ross Products Division, Abbott Laboratories)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Included patients MUST start enteral feeding within 12 hours after fulfillment of all inclusion criteria to be considered evaluable
  • 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

Exclusion Criteria:

  • 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
  • Participation in other clinical trial less than 30 days before inclusion in this trial
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329680

Locations
Brazil
Hospital Português - Real Sociedade Portuguesa 16 de Setembro
Salvador, Bahia, Brazil, 40.130-030
Hospital Salvador
Salvador, Bahia, Brazil, 40.130-030
Hospital Fernandes Távora - Adult Intensive Care Unit
Fortaleza, Ceara, Brazil, 60.115-000
Hospital Santa Luzia
Brasília, DF, Brazil
Hospital de Clínicas da Universidade Federal da Paraíba
João Pessoa, Paraíba, Brazil, 60000000
Associação Beneficente Evangélica de Joinville - Hospital Dona Helena
Joinville, Santa Catarina, Brazil, 89.204-050
Centro Hospitalar Unimed
Joinville, Santa Catarina, Brazil, 89.204-060
Fundação Faculdade de Medicina de São José Do Rio Preto
São José Do Rio Preto, São Paulo, Brazil, 15.090-000
Hospital Pró-Cardíaco
Rio de Janeiro, Brazil, 21000000
Clínica São Vicente
Rio de Janeiro, Brazil, 21000000
Instituto de Assistência Médica Ao Servidor Público Estadual-Iamspe
São Paulo, Brazil, 04.039-901
Hospital São Paulo-UNIFESP
São Paulo, Brazil, 04.024-900
Sponsors and Collaborators
Fernandes Tavora Hospital
Abbott
Investigators
Principal Investigator: Alessandro Pontes-Arruda, MD, PhD Hospital Fernandes Távora
  More Information

No publications provided

Responsible Party: Alessandro Pontes-Arruda Md, MSc, PhD, Fernandes Távora Hospital - CEJPLR - Intensive Care and Nutrition Department
ClinicalTrials.gov Identifier: NCT00329680     History of Changes
Other Study ID Numbers: ILAS-04-ABT
Study First Received: May 23, 2006
Last Updated: December 30, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Fernandes Tavora Hospital:
Sepsis
Severe Sepsis
Septic Shock
Enteral Nutrition
Antioxidants
EPA
GLA
Nutrition
Intensive Care
ICU

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antioxidants
Vitamins
Efamol
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014