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

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ClinicalTrials.gov Identifier: NCT00798681
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : August 10, 2010
Sponsor:
Collaborators:
Hospital Bandeirantes
Hospital Santa Luzia
Hospital Samaritano
Hospital da Polícia Militar
Sanatório Los Arcos
Sanatório Trinidad Palermo
Hospital Roosevelt
Information provided by:
Fernandes Tavora Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Dietary Supplement: RTU TPN with olive oil as the primary lipid source Other: CNF Parenteral nutrition Other: CNF parenteral nutrition Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EPICOS- Evaluating the Influence of RTU Parenteral Nutrition in the Clinical Outcome Patients Study
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Patients will receive RTU TPN with olive-oil as the primary source of lipids
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 Name: OliClinomel, Baxter Healthcare

Active Comparator: 2
CNF parenteral nutrition made with olive oil as the primary source of lipids
Other: CNF Parenteral nutrition
CNF parenteral nutrition made with olive oil as the primary source of lipids
Other Name: ClinOleic, Baxter Healthcare

Active Comparator: 3
CNF parenteral nutrition made with LCT/MCT 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
Other Name: LCT/MCT providers may vary




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 28-days all cause mortality [ Time Frame: 28-days follow-up period ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Number of new organ failures [ Time Frame: 28-days follow-up period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798681


Locations
Argentina
Sanatorio Los Arcos
Buenos Aires, Argentina
Sanatorio Trinidad Palermo
Buenos Aires, Argentina
Brazil
Fernandes Tavora Hospital
Fortaleza, CE, Brazil, 60.115-000
Hospital Santa Luzia
Brasilia, DF, Brazil, 70390-010
Hospital da Polícia Militar
Rio de Janeiro, RJ, Brazil, 22271-110
Hospital Samaritano
Rio de Janeiro, RJ, Brazil, 22271-110
Hospital Bandeirantes
São Paulo, SP, Brazil, 01506-000
Guatemala
Hospital Roosevelt
Guatemala City, Guatemala
Sponsors and Collaborators
Fernandes Tavora Hospital
Hospital Bandeirantes
Hospital Santa Luzia
Hospital Samaritano
Hospital da Polícia Militar
Sanatório Los Arcos
Sanatório Trinidad Palermo
Hospital Roosevelt
Investigators
Principal Investigator: Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM Fernandes Tavora Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alessandro Pontes-Arruda, MD MSc PhD FCCM, Fernandes Tavora Hospital
ClinicalTrials.gov Identifier: NCT00798681     History of Changes
Other Study ID Numbers: HFT-001/2008-BR
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: August 10, 2010
Last Verified: July 2010

Keywords provided by Fernandes Tavora Hospital:
parenteral nutrition
ready-to-use
customized nutrition formulation
olive oil
soybean oil
LCT/MCT
Clinoleic
oliclinomel
number of infections associated with TPN delivery system
BSI
Infection rates