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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, Guillermo E. MD; Spiegelman, Ronnie PharmD; Zhao, Vivian PharmD; Smiley, Dawn D. MD; Pinzon, Ingrid MD; Griffith, Daniel P. RPh; Peng, Limin PhD; Morris, Timothy BS; Luo, Menghua MD, PhD; Garcia, Hermes MD; Thomas, Christopher BA; Newton, Christopher A. MD; Ziegler, Thomas R. MD

doi: 10.1097/CCM.0b013e3182474bf9
Clinical Investigations

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.

From the Department of Medicine (GEU, RS, DDS, IP, TM, ML, HG, CT, CAN, TRZ), Emory University Hospital Nutrition and Metabolic Support Service (VZ, DPG, TRZ), and Rollins School of Public Health (LP), Emory University, Atlanta, GA.

*See also p. 1974.

Currently listed as clinicalTrials.gov NCT 00672854.

This investigator-initiated study was supported by a research grant from Baxter Pharmaceuticals (Dr. Umpierrez) and National Institutes of Health UL1 RR025008 (Atlanta Clinical and Translational Science Institute), American Diabetes Association 7-03-CR-35 (Dr. Umpierrez). Dr. Smiley receives research support from the National Institute of Health (K08 DK0830361). Dr. Ziegler receives research support from the National Institute of Health (K24 RR023356). The remaining authors have not disclosed any potential conflicts of interest.

Dr. Umpierrez contributed to study design, interpreting data, and in writing the manuscript. Mr. Spiegelman, Mr. Zhao, Dr. Pinzon, Mr. Griffith, Dr. Garcia, Dr. Luo, and Mr. Thomas contributed to acquiring data, checking accuracy of data, and interpreting data. Drs. Smiley and Newton contributed to study design, checking accuracy of data, interpreting data, and revising the manuscript. Dr. Peng conducted the statistical analysis and contributed to interpreting the data and revising the manuscript. Mr. Morris contributed to database management and interpreting data. Dr. Ziegler contributed to study design, interpreting data, and in revising the manuscript. This study was presented as an oral presentation at the Annual Endocrine Society Meeting in June 2011.

Drs. Umpierrez and Smiley received funding from the National Institutes of Health. The remaining authors have not disclosed any potential conflicts of interest.

For information regarding this article, E-mail: geumpie@emory.edu

© 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins