- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00798681
Evaluating the Influence of Ready-to-use (RTU) Parenteral Nutrition in the Clinical Outcome of Patients Study (EPICOS)
EPICOS- Evaluating the Influence of RTU Parenteral Nutrition in the Clinical Outcome Patients Study
Study Overview
Status
Conditions
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 nutrition (RTU). Although CNF is possibly associated with elevated infection rates, delay in the start of enteral nutrition and worse clinical outcomes there is no strong scientific evidence in the literature to support that the use of RTU is indeed associated with better clinical outcomes.
The use of closed ready-to-use parenteral nutrition systems is probably associated with less infection rates and better clinical outcomes including less time at the hospital and at the intensive care unit, less consumption of hospital resources and most likely lower mortality rates as well as early initiation of parenteral nutrition support. The aim of this study is to evaluate all the above mentioned parameters in contrast with those observed when using CNF parenteral nutrition.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Sanatorio Los Arcos
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Buenos Aires, Argentina
- Sanatorio Trinidad Palermo
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CE
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Fortaleza, CE, Brazil, 60.115-000
- Fernandes Tavora Hospital
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DF
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Brasilia, DF, Brazil, 70390-010
- Hospital Santa Luzia
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RJ
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Rio de Janeiro, RJ, Brazil, 22271-110
- Hospital da Polícia Militar
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Rio de Janeiro, RJ, Brazil, 22271-110
- Hospital Samaritano
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SP
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São Paulo, SP, Brazil, 01506-000
- Hospital Bandeirantes
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Guatemala City, Guatemala
- Hospital Roosevelt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Patients will receive RTU TPN with olive-oil as the primary source of lipids
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RTU will be provided as a 3 in 1 TPN ready-to-use TPN system in industrialized bags with 2.000 ml.
The number of calories will be adjusted in accordance with patients' individual needs.
Other Names:
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Active Comparator: 2
CNF parenteral nutrition made with olive oil as the primary source of lipids
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CNF parenteral nutrition made with olive oil as the primary source of lipids
Other Names:
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Active Comparator: 3
CNF parenteral nutrition made with LCT/MCT as the primary source of lipids
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3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of bloodstreams and catheter infection, as well as incidence of sepsis, severe sepsis and septic shock. Sepsis diagnostic criteria will be re-evaluated on a daily basis.
Time Frame: 28-day follow up
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28-day follow up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28-days all cause mortality
Time Frame: 28-days follow-up period
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28-days follow-up period
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Time to start parenteral nutrition, defined as the time from prescription to the effective start of infusion
Time Frame: Time from prescription to the effective start of TPN
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Time from prescription to the effective start of TPN
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Incidence of hyperglycemic events, defined as the number of times patients developed blood glucose levels over 110 mg/dL and over 150 mg/dL
Time Frame: For the duration of TPN
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For the duration of TPN
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Incidence of hypoglycemic events: defined as the number of times patients developed blood glucose levels bellow 60 mg/dL
Time Frame: For the duration of TPN
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For the duration of TPN
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Mean dose of insulin used (patients will receive insulin in order to maintain blood glucose levels <150 mg/dL (or 8.3 mmol/L) in accordance with the Surviving Sepsis Campaign Guidelines)
Time Frame: For the duration of TPN
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For the duration of TPN
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Use of hospital/ICU resources such as vasopressors, mechanical ventilation, need of hemodialysis, need of inotropic agents, antibiotics and sedatives
Time Frame: 28-days follow-up period
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28-days follow-up period
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ICU-free days, defined as the number of days from study entry (baseline) to the actual day that a patient remained on the ICU during the 28-days follow up period
Time Frame: 28-days follow-up period
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28-days follow-up period
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Number of new organ failures
Time Frame: 28-days follow-up period
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28-days follow-up period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM, Fernandes Tavora Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HFT-001/2008-BR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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