NCT00798681

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

EPICOS- Evaluating the Influence of RTU Parenteral Nutrition in the Clinical Outcome Patients Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Fernandes Tavora Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Parenteral Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	RTU TPN with olive oil as the primary lipid source	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	CNF Parenteral nutrition	CNF parenteral nutrition made with olive oil as the primary source of lipids
OTHER	CNF parenteral nutrition	3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-11-26
• Last updated: 2010-08-10

Locations

8 sites across 3 countries: Argentina, Brazil, Guatemala