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.

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.

Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects.

CONTEXT: Soybean oil-based lipid emulsions are the only Food and Drug Administration-approved lipid formulation for clinical use in parenteral nutrition (PN). Recently concerns with its use have been raised due to the proinflammatory effects that may lead to increased complications because they are rich in ω-6 polyunsaturated fatty acids. METHODS: This was a prospective, randomized, controlled, crossover study comparing the vascular, metabolic, immune, and inflammatory effects of 24-h infusion of PN containing soybean oil-based lipid emulsion (Intralipid), olive oil-based (ClinOleic), lipid free, and normal saline in 12 healthy subjects. RESULTS: Soybean oil-PN increased systolic blood pressure compared with olive oil-PN (P < 0.05). Soybean oil PN reduced brachial artery flow-mediated dilatation from baseline (-23% at 4 h and -25% at 24 h, both P < 0.01); in contrast, olive oil PN, lipid free PN, and saline did not change either systolic blood pressure or flow-mediated dilatation. Compared with saline, soybean oil PN, olive oil PN, and lipid free PN similarly increased glucose and insulin concentrations during infusion (P < 0.05). There were no significant changes in plasma free fatty acids, lipid profile, inflammatory and oxidative stress markers, immune function parameters, or sympathetic activity between soybean oil- and olive oil-based lipid emulsions. CONCLUSION: The 24-h infusion of PN containing soybean oil-based lipid emulsion increased blood pressure and impaired endothelial function compared with PN containing olive oil-based lipid emulsion and lipid-free PN in healthy subjects. These vascular changes may have significant implications in worsening outcome in subjects receiving nutrition support. Randomized controlled trials with relevant clinical outcome measures are needed in patients receiving PN with olive oil-based and soybean oil-based lipid emulsions.

Hyperglycemia is associated with increased hospital complications and mortality during parenteral nutrition.

OBJECTIVE: Hyperglycemia is a recognized complication of parenteral nutrition (PN). We aimed to determine the impact of hyperglycemia during PN unaccompanied by tight blood glucose (BG) control on hospital complications and mortality. METHODS: We reviewed the medical records of 276 medical and surgical patients receiving PN to determine the impact of hyperglycemia on survival after adjusting for known prognostic factors, and to determine whether BG levels before initiation of PN, within 24 hours of PN initiation, or during PN therapy are predictive of adverse outcomes. RESULTS: A total of 276 medical (35%) and surgical (65%) patients receiving PN initiated 12 ± 12 days after admission for a mean of 15 ± 24 days. Deceased patients (27.2%) were older, had higher Acute Physiology and Chronic Health Evaluation II scores, and had higher BG levels during PN therapy versus survivors (all, P < 0.01). Deceased patients had higher BG levels within 24 hours of PN initiation (162 ± 55 mg/dL vs 139 ± 37 mg/dL; P = 0.003) and higher BG levels during days 2 to 10 of PN (161 ± 53 mg/dL vs 142 ± 34 mg/dL; P = 0.013) compared with survivors. Blood glucose levels were associated with increased odds ratio (OR) for mortality pre-PN (P = 0.008), within 24 hours of PN initiation (P < 0.001), and during days 2 to 10 of PN (P < 0.001). In multiple regression models adjusted for age, sex, and history of diabetes, mortality was independently associated with pre-PN BG levels 121 to 150 mg/dL (OR, 2.2; 95% confidence interval [CI], 1.1-4.4), 151 to 180 mg/dL (OR, 3.41; 95% CI, 1.3-8.7,), and > 180 mg/dL (OR, 2.2; 95% CI, 0.9-5.2), and with BG levels within 24 hours of PN initiation > 180 mg/dL (OR, 2.8; 95% CI, 1.2-6.8). A BG level > 180 mg/dL within 24 hours of PN initiation was associated with increased risk of pneumonia (OR, 3.1; 95% CI, 1.4-7.1) and acute renal failure (OR, 2.3; 95% CI, 1.1-5.0). CONCLUSION: Hyperglycemia during PN without tight BG control is associated with increased risk of hospital complications and mortality. Randomized controlled trials are needed to determine benefits of intensified glycemic control on clinical outcomes in hospitalized subjects receiving PN.

Hyperglycemia during total parenteral nutrition: an important marker of poor outcome and mortality in hospitalized patients.

OBJECTIVE: To determine the effect of total parenteral nutrition (TPN)-induced hyperglycemia on hospital outcome. RESEARCH DESIGN AND METHODS: The study determined whether blood glucose values before, within 24 h, and during days 2-10 of TPN are predictive of hospital complications and mortality. RESULTS: Subjects included a total of 276 patients receiving TPN for a mean duration of 15 +/- 24 days (+/-SD). In multiple regression models adjusted for age, sex, and diabetes status, mortality was independently predicted by pre-TPN blood glucose of 121-150 mg/dl (odds ratio [OR] 2.2, 95% CI 1.1-4.4, P = 0.030), 151-180 mg/dl (3.41, 1.3-8.7, P = 0.01), and >180 mg/dl (2.2, 0.9-5.2, P = 0.077) and by blood glucose within 24 h of >180 mg/dl (2.8, 1.2-6.8, P = 0.020). A blood glucose within 24 h of >180 mg/dl was associated with increased risk of pneumonia (OR 3.1, 95% CI 1.4-7.1) and acute renal failure (2.3, 1.1-5.0). CONCLUSIONS: Hyperglycemia is associated with increased hospital complications and mortality in patients receiving TPN.