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

Parenteral Nutrition Clinical Trial

— EPICOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798681
• Other study ID #: HFT-001/2008-BR
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2008
• Last updated: August 9, 2010
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Fernandes Tavora Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

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
• CNF parenteral nutrition
3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids

Locations

Country	Name	City	State
Argentina	Sanatorio Los Arcos	Buenos Aires
Argentina	Sanatorio Trinidad Palermo	Buenos Aires
Brazil	Hospital Santa Luzia	Brasilia	DF
Brazil	Fernandes Tavora Hospital	Fortaleza	CE
Brazil	Hospital da Polícia Militar	Rio de Janeiro	RJ
Brazil	Hospital Samaritano	Rio de Janeiro	RJ
Brazil	Hospital Bandeirantes	São Paulo	SP
Guatemala	Hospital Roosevelt	Guatemala City

Sponsors (8)

Lead Sponsor	Collaborator
Fernandes Tavora Hospital	Hospital Bandeirantes, Hospital da Polícia Militar, Hospital Roosevelt, Hospital Samaritano, Hospital Santa Luzia, Sanatório Los Arcos, Sanatório Trinidad Palermo

Countries where clinical trial is conducted

Argentina,  Brazil,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28-day follow up	No
Secondary	28-days all cause mortality		28-days follow-up period	No
Secondary	Time to start parenteral nutrition, defined as the time from prescription to the effective start of infusion		Time from prescription to the effective start of TPN	No
Secondary	Incidence of hyperglycemic events, defined as the number of times patients developed blood glucose levels over 110 mg/dL and over 150 mg/dL		For the duration of TPN	No
Secondary	Incidence of hypoglycemic events: defined as the number of times patients developed blood glucose levels bellow 60 mg/dL		For the duration of TPN	No
Secondary	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)		For the duration of TPN	No
Secondary	Use of hospital/ICU resources such as vasopressors, mechanical ventilation, need of hemodialysis, need of inotropic agents, antibiotics and sedatives		28-days follow-up period	No
Secondary	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		28-days follow-up period	No
Secondary	Number of new organ failures		28-days follow-up period	No