Clinical trial NCT00798681: Evaluating the Influence of Ready-to-use (RTU) Parenteral Nutrition in the Clinical Outcome of Patients Study
Official title: EPICOS- Evaluating the Influence of RTU Parenteral Nutrition in the Clinical Outcome Patients Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parenteral Nutrition
Keywords: 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
Lead sponsor: Fernandes Tavora Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Bandeirantes
name: Hospital Santa Luzia
name: Hospital Samaritano
name: Hospital da Polícia Militar
name: Sanatório Los Arcos
name: Sanatório Trinidad Palermo
name: Hospital Roosevelt
First posted: 2008-11-26
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 28-day follow up
Secondary outcomes:
measure: 28-days all cause mortality
timeFrame: 28-days follow-up period
measure: Time to start parenteral nutrition, defined as the time from prescription to the effective start of infusion
timeFrame: Time from prescription to the effective start of TPN
measure: Incidence of hyperglycemic events, defined as the number of times patients developed blood glucose levels over 110 mg/dL and over 150 mg/dL
timeFrame: For the duration of TPN
measure: Incidence of hypoglycemic events: defined as the number of times patients developed blood glucose levels bellow 60 mg/dL
timeFrame: For the duration of TPN
measure: 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)
timeFrame: For the duration of TPN
measure: Use of hospital/ICU resources such as vasopressors, mechanical ventilation, need of hemodialysis, need of inotropic agents, antibiotics and sedatives
timeFrame: 28-days follow-up period
measure: 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
timeFrame: 28-days follow-up period
measure: Number of new organ failures
timeFrame: 28-days follow-up period
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanatorio Los Arcos
city: Buenos Aires
country: Argentina
facility: Sanatorio Trinidad Palermo
city: Fortaleza
country: Brazil
facility: Fernandes Tavora Hospital
state: CE
city: Brasilia
country: Brazil
facility: Hospital Santa Luzia
state: DF
city: Rio de Janeiro
country: Brazil
facility: Hospital da Polícia Militar
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Samaritano
state: RJ
city: São Paulo
country: Brazil
facility: Hospital Bandeirantes
state: SP
city: Guatemala City
country: Guatemala
facility: Hospital Roosevelt
Study officials:
affiliation: Fernandes Tavora Hospital
name: Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pontes-Arruda A, Dos Santos MC, Martins LF, Gonzalez ER, Kliger RG, Maia M, Magnan GB; EPICOS Study Group. Influence of parenteral nutrition delivery system on the development of bloodstream infections in critically ill patients: an international, multicenter, prospective, open-label, controlled study--EPICOS study. JPEN J Parenter Enteral Nutr. 2012 Sep;36(5):574-86. doi: 10.1177/0148607111427040. Epub 2012 Jan 23.