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Sponsors and Collaborators: |
Fernandes Tavora Hospital Abbott Ross Products (a Division of Abbott Laboratories) |
Information provided by: | Fernandes Tavora Hospital |
ClinicalTrials.gov Identifier: | NCT00329680 |
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 |
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 |
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
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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
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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
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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
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Fernandes Tavora Hospital |
Abbott |
Ross Products (a Division of Abbott Laboratories) |
Principal Investigator: | Alessandro Pontes-Arruda, MD, PhD | Hospital Fernandes Távora |
Latin American Sepsis Institute Homepage 
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Intersept Study Web-Based Collection Database (Electronic CRF) - Access Limited to the Investigation Centers 
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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 |
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