Status:
COMPLETED
The Effects of Eicosapentaenoic Acid (EPA), Gamma-Linolenic Acid (GLA) and Antioxidants in the Treatment of Sepsis
Lead Sponsor:
Fernandes Tavora Hospital
Collaborating Sponsors:
Abbott
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mechanic...
Detailed Description
The effectiveness of nutritional support in modulating the chain of inflammatory response and in reducing demands of the respiratory system through use of nutritional intervention has received a growi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00329680
Start Date
June 1 2007
End Date
October 1 2009
Last Update
December 31 2009
Active Locations (12)
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1
Hospital Fernandes Távora - Adult Intensive Care Unit
Fortaleza, Ceará, Brazil, 60.115-000
2
Hospital Português - Real Sociedade Portuguesa 16 de Setembro
Salvador, Estado de Bahia, Brazil, 40.130-030
3
Hospital Salvador
Salvador, Estado de Bahia, Brazil, 40.130-030
4
Hospital Santa Luzia
Brasília, Federal District, Brazil