The Effects of Eicosapentaenoic Acid (EPA), Gamma-Linolenic Acid (GLA) and Antioxidants in the Treatment of Sepsis
This study has been completed.
Sponsor:
Fernandes Tavora Hospital
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
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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
Additional 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 May 16, 2013