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

Crit Care Med. 2012 Jun;40(6):1792-8. doi: 10.1097/CCM.0b013e3182474bf9.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00672854.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Critical Care
  • Double-Blind Method
  • Fat Emulsions, Intravenous / administration & dosage*
  • Female
  • Humans
  • Intensive Care Units
  • Male
  • Middle Aged
  • Olive Oil
  • Parenteral Nutrition / methods*
  • Plant Oils / administration & dosage*
  • Prospective Studies
  • Soybean Oil / administration & dosage*
  • Surgical Procedures, Operative
  • Treatment Outcome

Substances

  • Fat Emulsions, Intravenous
  • Olive Oil
  • Plant Oils
  • Soybean Oil

Associated data

  • ClinicalTrials.gov/NCT00672854