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

This study is currently recruiting participants.
Verified by Fernandes Tavora Hospital, May 2008

Sponsors and Collaborators: Fernandes Tavora Hospital
Abbott
Ross Products (a Division of Abbott Laboratories)
Information provided by: Fernandes Tavora Hospital
ClinicalTrials.gov Identifier: NCT00329680
  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: Eixosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins
Dietary Supplement: Standard ICU enteral diet, isocaloric to the study diet
Phase IV

MedlinePlus related topics:   Antioxidants    Dietary Supplements    Sepsis   

ChemIDplus related topics:   gamma-Linolenic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Investigating Nutritional Therapy With EPA, GLA and Antioxidants Role in Sepsis Treatment-INTERSEPT STUDY

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 ]

Estimated Enrollment:   200
Study Start Date:   June 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Experimental arm will receive an enteral diet enriched with EPA, GLA and Antioxidant vitamins
Dietary Supplement: Eixosapentaenoic 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 atending physisian/family/patient to no longer participate in this clinical study
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
Patients will receive this diet in a blinded way using the same dose regimen specified previously and used in the study group

Show detailed description  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., [40] and modified in accordance with Bernard GR et al. [30]. Included patients MUST start enteral feeding within 12 hours after fulfillment of all inclusion criteria to be considered evaluable. In adition, 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 hemodyalisis 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, or 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

Contacts
Contact: Alessandro Pontes-Arruda, MD, PhD     +55-85-32282555 ext 233     pontes-arruda@secrel.com.br    
Contact: Carla Silva, RN     +55-11-37216709     carla@sepsisnet.org    

Locations
Brazil
Hospital Pró-Cardíaco     Recruiting
      Rio de Janeiro, Brazil, 21000000
      Contact: Fernando Gutierrez, MD     55-21-25270877     flgutierrez@hotmail.com    
      Principal Investigator: Fernando Gutierrez, MD            
      Sub-Investigator: Rubens Costa Filho, MD            
Clínica São Vicente     Completed
      Rio de Janeiro, Brazil, 21000000
Hospital São Paulo-UNIFESP     Completed
      São Paulo, Brazil, 04.024-900
Instituto De ASSISTÊNCIA MÉDICA Ao Servidor PÚBLICO Estadual-Iamspe     Recruiting
      São Paulo, Brazil, 04.039-901
      Contact: Ederlon AC Rezende, MD     55-11-50888146     ederlon@sti-hspe.com.br    
      Principal Investigator: Ederlon AC Rezende, MD            
Brazil, Bahia
Hospital PORTUGUÊS - Real Sociedade Portuguesa 16 De Setembro     Completed
      Salvador, Bahia, Brazil, 40.130-030
Hospital Salvador     Recruiting
      Salvador, Bahia, Brazil, 40.130-030
      Contact: José Mário M Teles, MD     55-71-99750909     zemario@atarde.com.br    
      Principal Investigator: José Mário M Teles, MD            
Brazil, Ceara
Hospital Fernandes Távora - Adult Intensive Care Unit     Recruiting
      Fortaleza, Ceara, Brazil, 60.115-000
      Contact: Laércia Martins, RN     +55-85-32282555 ext 233     laerciamartins@gmail.com    
      Contact: Luisa Mendonça     +55-85-32282555 ext 233     luisa-marcelo@hotmail.com    
      Principal Investigator: Alessandro Pontes-Arruda, MD, PhD            
Brazil, DF
Hospital Santa Luzia     Recruiting
      Brasília, DF, Brazil
      Contact: Marcelo O Maia, MD     55-61-34456301     marcelom@hsl.com.br    
      Principal Investigator: Marcelo de Oliveira Maia, MD            
Brazil, Paraíba
Hospital de Clínicas da Universidade Federal da Paraíba     Recruiting
      João Pessoa, Paraíba, Brazil, 60000000
      Contact: Ciro L Mendes, MD     55-83-93820931     ciro.l.mendes@gmail.com    
      Principal Investigator: Ciro L Mendes, MD            
Brazil, São Paulo
FUNDAÇÃO Faculdade De Medicina De SÃO JOSÉ Do Rio Preto     Completed
      São José do Rio Preto, São Paulo, Brazil, 15.090-000
Brazil, Santa Catarina
ASSOCIAÇÃO Beneficente EVANGÉLICA De Joinville - Hospital Dona Helena     Completed
      Joinville, Santa Catarina, Brazil, 89.204-050
Centro Hospitalar Unimed     Completed
      Joinville, Santa Catarina, Brazil, 89.204-060

Sponsors and Collaborators
Fernandes Tavora Hospital
Abbott
Ross Products (a Division of Abbott Laboratories)

Investigators
Principal Investigator:     Alessandro Pontes-Arruda, MD, PhD     Hospital Fernandes Távora    
  More Information


Latin American Sepsis Institute Homepage  This link exits the ClinicalTrials.gov site
 
Intersept Study Web-Based Collection Database (Electronic CRF) - Access Limited to the Investigation Centers  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Fernandes Távora Hospital - CEJPLR - Intensive Care and Nutrition Department ( Alessandro Pontes-Arruda Md, MSc, PhD )
Study ID Numbers:   ILAS-04-ABT
First Received:   May 23, 2006
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00329680
Health Authority:   Brazil: National Committee of Ethics in Research;   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

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Efamol
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 07, 2008




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