A Phase 4 interventional study of RTU TPN with olive oil as the primary lipid source and CNF Parenteral nutrition in Parenteral Nutrition, sponsored by Fernandes Tavora Hospital. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-10.
Sponsored by Fernandes Tavora Hospital · Phase 4, Interventional, and Treatment
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.
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.
Fernandes Tavora Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
CNF parenteral nutrition made with olive oil as the primary source of lipids
Other: CNF Parenteral nutrition
CNF parenteral nutrition made with LCT/MCT as the primary source of lipids
Other: CNF parenteral nutrition
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.
Also known as: OliClinomel, Baxter Healthcare
CNF parenteral nutrition made with olive oil as the primary source of lipids
Also known as: ClinOleic, Baxter Healthcare
3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids
Also known as: LCT/MCT providers may vary
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
28-days all cause mortality
Time frame: 28-days follow-up period
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
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
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
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
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
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
Number of new organ failures
Time frame: 28-days follow-up period
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Fernandes Tavora Hospital