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| Name | Class |
|---|---|
| Hospital Bandeirantes | OTHER |
| Hospital Santa Luzia | UNKNOWN |
| Hospital Samaritano | UNKNOWN |
| Hospital da Polícia Militar |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will receive RTU TPN with olive-oil as the primary source of lipids |
|
| 2 | Active Comparator | CNF parenteral nutrition made with olive oil as the primary source of lipids |
|
| 3 | Active Comparator | CNF parenteral nutrition made with LCT/MCT as the primary source of lipids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTU TPN with olive oil as the primary lipid source | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-days all cause mortality | 28-days follow-up period | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM | Fernandes Tavora Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Los Arcos | Buenos Aires | Argentina | ||||
| Sanatorio Trinidad Palermo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22269899 | Derived | 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. |
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| UNKNOWN |
| Sanatório Los Arcos | UNKNOWN |
| Sanatório Trinidad Palermo | UNKNOWN |
| Hospital Roosevelt | UNKNOWN |
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|
| CNF Parenteral nutrition | Other | CNF parenteral nutrition made with olive oil as the primary source of lipids |
|
|
| CNF parenteral nutrition | Other | 3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids |
|
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| 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 |
| Incidence of hypoglycemic events: defined as the number of times patients developed blood glucose levels bellow 60 mg/dL | 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) | 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 | 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 | 28-days follow-up period |
| Number of new organ failures | 28-days follow-up period |
| Buenos Aires |
| Argentina |
| Fernandes Tavora Hospital | Fortaleza | Ceará | 60.115-000 | Brazil |
| Hospital Santa Luzia | Brasília | Federal District | 70390-010 | Brazil |
| Hospital da Polícia Militar | Rio de Janeiro | Rio de Janeiro | 22271-110 | Brazil |
| Hospital Samaritano | Rio de Janeiro | Rio de Janeiro | 22271-110 | Brazil |
| Hospital Bandeirantes | São Paulo | São Paulo | 01506-000 | Brazil |
| Hospital Roosevelt | Guatemala City | Guatemala |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| C568346 | ClinOleic |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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