Evaluating the Influence of Ready-to-use (RTU) Parenteral Nutrition in the Clinical Outcome of Patients Study (EPICOS)

Fernandes Tavora Hospital

Status and phase: Completed; Phase 4

Conditions: Parenteral Nutrition

Treatments: Other: CNF parenteral nutrition; Other: CNF Parenteral nutrition; Dietary Supplement: RTU TPN with olive oil as the primary lipid source

Study type: Interventional

Funder types: Other

Identifiers

NCT00798681

HFT-001/2008-BR

Details and patient eligibility

About

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 investigate the effects of closed parenteral nutrition systems when compared to open parenteral nutrition systems in terms of several clinical outcomes.

Full 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.

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 3 patient groups

1

Experimental group

Description:

Patients will receive RTU TPN with olive-oil as the primary source of lipids

Treatment:

Dietary Supplement: RTU TPN with olive oil as the primary lipid source

2

Active Comparator group

Description:

CNF parenteral nutrition made with olive oil as the primary source of lipids

Treatment:

Other: CNF Parenteral nutrition

3

Active Comparator group

Description:

CNF parenteral nutrition made with LCT/MCT as the primary source of lipids

Treatment:

Other: CNF parenteral nutrition