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

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.

Conditions

• Parenteral Nutrition

Interventions

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

Sponsors & Collaborators

• Hospital Bandeirantes

  collaborator OTHER

• Hospital Santa Luzia

  collaborator UNKNOWN

• Hospital Samaritano

  collaborator UNKNOWN

• Hospital da Polícia Militar

  collaborator UNKNOWN

• Sanatório Los Arcos

  collaborator UNKNOWN

• Sanatório Trinidad Palermo

  collaborator UNKNOWN

• Hospital Roosevelt

  collaborator UNKNOWN

• Fernandes Tavora Hospital

  lead OTHER

Principal Investigators

• Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM · Fernandes Tavora Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2010-07-31

Completion

2010-07-31

Countries

• Argentina
• Brazil
• Guatemala

Study Locations