Status:
COMPLETED
Evaluating the Influence of Ready-to-use (RTU) Parenteral Nutrition in the Clinical Outcome of Patients Study
Lead Sponsor:
Fernandes Tavora Hospital
Collaborating Sponsors:
Hospital Bandeirantes
Hospital Santa Luzia
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an international prospective randomized multicenter open-label controlled study. The primary center will be Fernandes Távora Hospital (Fortaleza, Ceará). The aim of this study is to investigat...
Detailed Description
In most Latin-American countries individually customized nutrition formulations (CNF) remains the gold-standard for parenteral nutrition in opposition to industrialized ready-to-use parenteral nutriti...
Eligibility Criteria
Inclusion
- Patients over 18 years of age with recommendation to use total parenteral nutrition.
- Caloric goals will be calculated using BEE adjusted by the pathology of the patient. In addition, patients MUST achieve at least once 75% of BEE (calculated using the Harris-Benedict equation) to be considered evaluable. Caloric intake will be accessed in a daily basis.
- This study will be performed in accordance with all ethics statements of the Helsinki's Declaration (52nd General Assembly of the World Medical Association, Edinburgh, Scotland, October, 2000), and of the Nuremberg Code.
- In addition, this study must be approved by the Institutional Review Board before patient enrollment and by the Federal Council of Research and Ethics of the Ministry of Health.
- All participating institutions will also be requested to observe Good Clinical Practice Guidelines and all federal laws and regulations.
- An informed consent will be obtained from all patients or their legal representatives before any study related procedure.
Exclusion
- 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, participation in other clinical trial less than 3 months before inclusion in this trial
- Head trauma with a Glasgow Come Score (GCS) less or equal to 5
- Severe immunologic suppression (defined as a leukocyte count bellow 5.000 cells/mm3)
- Infection by the human immunodeficiency virus
- Patients with no indication for parenteral feeding or in the imminence of receiving enteral nutrition
- Patients receiving partial parenteral nutrition in order to achieve caloric goal, or patient's, patient's legal representative or physicians decision to exclude patients from this protocol.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00798681
Start Date
July 1 2008
End Date
July 1 2010
Last Update
August 10 2010
Active Locations (8)
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1
Sanatorio Los Arcos
Buenos Aires, Argentina
2
Sanatorio Trinidad Palermo
Buenos Aires, Argentina
3
Fernandes Tavora Hospital
Fortaleza, Ceará, Brazil, 60.115-000
4
Hospital Santa Luzia
Brasília, Federal District, Brazil, 70390-010