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Ensayo controlado aleatorizado2012

A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition

Umpierrez GE, Spiegelman R, Zhao V, Smiley DD, Pinzon I, Griffith DP, Peng L, Morris T, Luo M, Garcia H, Thomas C, Newton CA, Ziegler TR

Critical care medicine · 44 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte
Consumo medido con
No se indica

Quién lo pagó

Financiación
Financiación independiente
Gobierno
National Institute of Diabetes and Digestive and Kidney Diseases
Gobierno
National Center for Research Resources
Gobierno
National Center for Advancing Translational Sciences
Gobierno
NIDDK NIH HHS
Gobierno
NCATS NIH HHS
Gobierno
NCRR NIH HHS
Subvenciones
National Institute of Diabetes and Digestive and Kidney Diseases (K08-DK-0830361); National Institute of Diabetes and Digestive and Kidney Diseases (K08DK083036); National Center for Advancing Translational Sciences (UL1 TR000454); National Center for Research Resources (K24 RR023356); National Center for Research Resources (UL1RR025008)

Según 6 financiadores declarados.

Publicación

Publicado
2012-04-08 · Crit Care Med · vol. 40 · número 6 · págs. 1792–1798
Editorial
Lippincott Williams & Wilkins
Citado
76 citas · más que el 99% de estudios similares · 10.0× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
46 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Clinical Nutrition and Gastroenterology · Hyperglycemia and glycemic control in critically ill and hospitalized patients · Central Venous Catheters and Hemodialysis
Palabras clave
parenteral nutrition, lipid emulsions, soybean oil, olive oil, Intralipid, ClinOleic, intensive care unit patients, nosocomial infections, acute kidney injury, inflammatory markers, oxidative stress, granulocyte function, monocyte function, glycemic control, length of hospital stay, mortality, critically ill adults
MeSH
humans, soybean oil, fat emulsions, intravenous, plant oils, treatment outcome, parenteral nutrition, critical care, surgical procedures, operative, prospective studies, double-blind method, adult, aged, middle aged, intensive care units, female, male, olive oil

13 autores

  • Guillermo E. Umpierrez🇺🇸Emory University; Emory University Hospital
  • Ronnie Spiegelman🇺🇸Emory University; Emory University Hospital
  • Vivian M. Zhao🇺🇸Emory University; Emory University Hospital
  • Dawn D. Smiley🇺🇸Emory University; Emory University Hospital
  • Ingrid Pinzon🇺🇸Emory University; Emory University Hospital
  • Daniel P. Griffith🇺🇸Emory University; Emory University Hospital
  • Limin Peng🇺🇸Emory University; Emory University Hospital
  • Timothy Morris🇺🇸Emory University; Emory University Hospital
  • Menghua Luo🇺🇸Emory University; Emory University Hospital
  • Hermes G. Garcia🇺🇸Emory University; Emory University Hospital
  • Christopher Thomas🇺🇸Emory University; Emory University Hospital
  • Christopher A. Newton🇺🇸Emory University; Emory University Hospital
  • Thomas R. Ziegler🇺🇸Emory University; Emory University Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

Objective

Parenteral nutrition has been associated with metabolic and infectious complications in intensive care unit patients. The underlying mechanism for the high risk of complications is not known but may relate to the proinflammatory effects of soybean oil-based lipid emulsions, the only Food and Drug Administration-approved lipid formulation for clinical use.

Design

Prospective, double-blind, randomized, controlled trial.

Setting

Medical-surgical intensive care units from a major urban teaching hospital and a tertiary referral university hospital.

Patients

Adult medical-surgical intensive care unit patients.

Intervention

Parenteral nutrition containing soybean oil-based (Intralipid) or olive oil-based (ClinOleic) lipid emulsions.

Measurements

Differences in hospital clinical outcomes (nosocomial infections and noninfectious complications), hospital length of stay, glycemic control, inflammatory and oxidative stress markers, and granulocyte and monocyte functions between study groups.

Results

A total of 100 patients were randomized to either soybean oil-based parenteral nutrition or olive oil-based parenteral nutrition for up to 28 days. A total of 49 patients received soybean oil-based parenteral nutrition (age 51 ± 15 yrs, body mass index 27 ± 6 kg/m2, and Acute Physiology and Chronic Health Evaluation II score 15.5 ± 7 [±SD]), and a total of 51 patients received olive oil-based lipid emulsion in parenteral nutrition (age 46 ± 19 yrs, body mass index 27 ± 8 kg/m2, and Acute Physiology and Chronic Health Evaluation II score 15.1 ± 6 [±SD]) for a mean duration of 12.9 ± 8 days. The mean hospital blood glucose concentration during parenteral nutrition was 129 ± 14 mg/dL, without differences between groups. Patients treated with soybean oil-based and olive oil-based parenteral nutrition had a similar length of stay (47 ± 47 days and 41 ± 36 days, p = .49), mortality (16.3% and 9.8%, p = .38), nosocomial infections (43% vs. 57%, p = .16), and acute renal failure (26% vs. 18%, p = .34). In addition, there were no differences in inflammatory and oxidative stress markers or in granulocyte and monocyte functions between groups.

Conclusion

The administration of parenteral nutrition containing soybean oil-based and olive oil-based lipid emulsion resulted in similar rates of infectious and noninfectious complications and no differences in glycemic control, inflammatory and oxidative stress markers, and immune function in critically ill adults.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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