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* (original) (raw)
Related papers
Clinical Nutrition, 2018
Background and aims: Data in critically ill patients on the effect of intravenous lipid emulsions (LEs), containing omega-3 polyunsaturated fatty acids (PUFAs), in parenteral nutrition (PN) are scarce and conflicting. This study compared the effects of a four-oil LE (30% soybean oil, 30% medium-chain triglycerides, 25% olive oil and 15% fish oil (FO)) (SMOFlipid®) to those of a 100% soybean oil-based LE in critically ill adult intensive care unit (ICU) patients. Methods: In this double-blind, randomised study, patients (n ¼ 75) predicted to need PN for more than 5 days were randomised to receive either a four-oil LE (Study Group (SG)) or a 100% soybean oil LE (Control Group (CG)). Isocaloric, isonitrogenous PN was administered continuously for 5 days. FO was provided at a dose of 0.09e0.22 g/kg body weight. Measurements included biochemical parameters and sequential organ failure assessment (SOFA) score daily and plasma total phospholipid fatty acids (FAs) and cytokine levels on days 1, 3, 6. Days on mechanical ventilation, length of stay and mortality were also recorded. ANOVA was used to compare response variables between the two groups over the time and Pearson correlation was used to measure relationships between continuous variables. Results: 68 patients completed the study (n ¼ 35 SG, n ¼ 33 CG), with male predominance (66% SG, 56% CG). Average age was 60.8 ± 13.9 years (SG) versus 55.7 ± 14.8 (CG) (p ¼ 0.143). The majority were surgical admissions (85% SG versus 91% CG) followed by medical. Plasma phospholipid oleic acid (p ¼ 0.022) and alpha-linolenic acid (p<0.0005) increased in both groups. In the SG, plasma phospholipid EPA and DHA increased (both p<0.001), whereas the omega-6:omega-3 PUFA (n-6:n-3 PUFA) ratio decreased (p < 0.001). Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin decreased in both treatment groups. Considering only the change from day 1 to day 6 there was a bigger decrease in AST, ALT and bilirubin levels in the SG. Concentrations of TNF-a decreased from day 1 to day 6 in the SG, whereas they increased in the CG, but the change was not statistically significant (p ¼ 0.112). A significant negative correlation was found between EPA provision on day 3 and the SOFA score (r ¼ À0.4047, p ¼ 0.018). Days on mechanical ventilation (1.24 ± 0.83 days in SG versus 0.88 ± 1.63 days in CG, p ¼ 0.385) and ICU LOS (9.5 ± 7.09 days in SG versus 10.7 ± 7.6 days in CG, p ¼ 0.490) were not different between groups. Conclusion: PN containing a four-oil LE increased plasma EPA and DHA, decreased n-6:n-3 PUFA ratio, and was safe and well tolerated. The negative relationship between day 3 EPA and SOFA score seems promising, but EPA intake and effects may have been diluted by enteral nutrition which was started in more than half of patients on day 4. There was no significant difference in terms of other biochemical
British Journal of Nutrition, 2005
Intravenous lipid emulsions (ILE) have demonstrated advantages including prevention of essential fatty acid (EFA) deficiency; however, too much EFA can down regulate fatty acid elongation leading to an imbalance of nutritional compounds in plasma and cell membranes. An olive oil-based ILE containing long-chain triacylglycerols (LCT) with a low content (20 %) of PUFA was administered for home parenteral nutrition (HPN) and compared with a conventional soyabean oil-based ILE (PUFA content, 60 %). Thirteen patients (26–92 years) with stable intestinal failure were randomised after a 1-month run-in period with a medium-chain triacylglycerols–LCT-based ILE, to receive 3 months of HPN with either olive oil- (n6) or soyabean oil-based (n7) ILE. The nutritional impact and safety of HPN, oral intakes and absorption rates, phospholipid fatty acids in plasma and lymphocyte cell membrane were assessed. The only clinical event reported was one case of pneumonia (soya group). In both groups, 20 :...
Pilot and Feasibility Studies
Background Home parenteral nutrition (HPN) can be associated with increased liver enzymes, catheter-related bloodstream infections (CRBSI), and hospitalizations. Mixed oil (MO) versus soybean oil (SO) lipid emulsion reduces risks in hospitalized patients, but there are no randomized double-blinded controlled trials in HPN. Therefore, the primary objective was to test the study’s feasibility such as recruitment and retention in the HPN population and the secondary objective was to assess changes in liver enzymes between MO and SO as well as other clinical and biochemical outcomes. Methods This 13-month prospective double-blind crossover randomized pilot trial took place in Toronto, Canada. Participants were HPN patients who were a part of the HPN program at Toronto General Hospital. We recruited patients from the HPN program. HPN patients receiving SO were randomized to either MO or SO, and the study duration was 6 months in each arm (MO or SO) with a 1-month washout period resuming ...
Clinical Nutrition, 2018
Background and aims: Data in critically ill patients on the effect of intravenous lipid emulsions (LEs), containing omega-3 polyunsaturated fatty acids (PUFAs), in parenteral nutrition (PN) are scarce and conflicting. This study compared the effects of a four-oil LE (30% soybean oil, 30% medium-chain triglycerides, 25% olive oil and 15% fish oil (FO)) (SMOFlipid®) to those of a 100% soybean oil-based LE in critically ill adult intensive care unit (ICU) patients. Methods: In this double-blind, randomised study, patients (n ¼ 75) predicted to need PN for more than 5 days were randomised to receive either a four-oil LE (Study Group (SG)) or a 100% soybean oil LE (Control Group (CG)). Isocaloric, isonitrogenous PN was administered continuously for 5 days. FO was provided at a dose of 0.09e0.22 g/kg body weight. Measurements included biochemical parameters and sequential organ failure assessment (SOFA) score daily and plasma total phospholipid fatty acids (FAs) and cytokine levels on days 1, 3, 6. Days on mechanical ventilation, length of stay and mortality were also recorded. ANOVA was used to compare response variables between the two groups over the time and Pearson correlation was used to measure relationships between continuous variables. Results: 68 patients completed the study (n ¼ 35 SG, n ¼ 33 CG), with male predominance (66% SG, 56% CG). Average age was 60.8 ± 13.9 years (SG) versus 55.7 ± 14.8 (CG) (p ¼ 0.143). The majority were surgical admissions (85% SG versus 91% CG) followed by medical. Plasma phospholipid oleic acid (p ¼ 0.022) and alpha-linolenic acid (p<0.0005) increased in both groups. In the SG, plasma phospholipid EPA and DHA increased (both p<0.001), whereas the omega-6:omega-3 PUFA (n-6:n-3 PUFA) ratio decreased (p < 0.001). Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin decreased in both treatment groups. Considering only the change from day 1 to day 6 there was a bigger decrease in AST, ALT and bilirubin levels in the SG. Concentrations of TNF-a decreased from day 1 to day 6 in the SG, whereas they increased in the CG, but the change was not statistically significant (p ¼ 0.112). A significant negative correlation was found between EPA provision on day 3 and the SOFA score (r ¼ À0.4047, p ¼ 0.018). Days on mechanical ventilation (1.24 ± 0.83 days in SG versus 0.88 ± 1.63 days in CG, p ¼ 0.385) and ICU LOS (9.5 ± 7.09 days in SG versus 10.7 ± 7.6 days in CG, p ¼ 0.490) were not different between groups. Conclusion: PN containing a four-oil LE increased plasma EPA and DHA, decreased n-6:n-3 PUFA ratio, and was safe and well tolerated. The negative relationship between day 3 EPA and SOFA score seems promising, but EPA intake and effects may have been diluted by enteral nutrition which was started in more than half of patients on day 4. There was no significant difference in terms of other biochemical
Controversies in the Use of Lipid Injectable Emulsion in Hospitalized Patients
Nutrition in Clinical Practice
Soybean oil–based lipid injectable emulsion (SO‐based ILE) is an 18‐carbon, ω‐6 macronutrient providing a concentrated source of calories, which can be administered in or with parenteral nutrition to patients unable to tolerate or consume adequate enteral nutrition. Beyond the provision of energy, SO‐based ILE provides linoleic and linolenic acid, 2 essential fatty acids necessary for the prevention of essential fatty acid deficiency. However, SO‐based ILE with its high levels of ω‐6 fatty acids, long‐chain triglycerides, phospholipid emulsifiers, and glycerin has been associated with worsening clinical outcomes, including increase of infections, lengthier intensive care and hospital stay, and prolonged mechanical ventilation. Recognizing this, studies have investigated omitting SO‐based ILE in the critically ill patient for the first 7 days to observe if clinical outcomes are improved. Unfortunately, there is extremely limited research, and what is available is controversial. Natio...
Change to Mixed-Lipid Emulsion From Soybean Oil–Based Lipid Emulsion in Pediatric Patients
JAMA Network Open
ImportanceCritically ill pediatric patients often require parenteral nutrition (PN) in the intensive care unit (ICU). Literature suggests mixed lipid emulsions (LE) with soybean oil reduction strategies may improve outcomes.ObjectiveTo examine the association of a hospital-wide switch to a mixed-lipid formula (4-OLE) with pediatric outcomes.Design, Setting, and ParticipantsRetrospective cohort study at a large US academic referral center. Pediatric patients aged 1 month to 17 years requiring parenteral nutrition from May 2016 to September 2019 were included. Data were analyzed from October 2020 to February 2023.ExposureIn 2017, Duke University Health System fully converted to a soybean oil/MCT/olive/fish oil lipid (4-OLE) from pure soybean oil–based LE in pediatric patients. Pediatric patients before the change (Intralipid [IL] group) were compared with patients after (4-OLE group).Main Outcomes and MeasuresClinical outcomes were compared between treatment periods via multivariable ...
Alternative lipid emulsions in the critically ill: a systematic review of the evidence
Intensive Care Medicine, 2013
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Intradialytic parenteral nutrition: comparison of olive oil versus soybean oilbasedlipid emulsions
British Journal of Nutrition, 2006
Lipid, oxidative and inflammatory parameters are frequently altered in dialysis patients and may be worsened by intravenous lipid emulsions (ILE). We assessed the efficacy and tolerance of olive as compared with standard soybean oil-based ILE during intradialytic parenteral nutrition (IDPN). IDPN mixtures containing amino acids, glucose, and either olive oil (OO group, n 17) or soybean oil-based ILE (SO group, n 18) were administered in a 5-week randomized, double-blind study. On days 0 and 35, patients' nutritional status was assessed by BMI, normalized protein catabolic rate, predialytic creatinine, serum albumin and transthyretin; lipid metabolism by plasma LDL-and HDL-cholesterol, triacylglycerols, phospholipids, apo A-I, A-II, B, C-II, C-III, E and lipoprotein (a); oxidative status by a-tocopherol, retinol, selenium, glutathione peroxidase, malondialdehyde and advanced oxidized protein products; inflammatory status by serum C-reactive protein, orosomucoid, IL-2 and IL-6. No serious adverse event was observed. Significant changes were observed from day 0 to day 35 (P,0•05): nutritional criteria improved (albumin in OO; albumin, transthyretin and creatinine in SO); LDL-cholesterol, apo B, C-II, C-III and apo A-I/A-II ratio increased in both groups. HDL-cholesterol decreased in OO; apo E increased and lipoprotein (a) decreased in SO; a-tocopherol/cholesterol ratio increased in OO; malondialdehyde decreased in both groups; IL-2 increased in both groups. The between-group comparison only showed the following differences: a-tocopherol/cholesterol increased in OO; lipoprotein (a) decreased in SO. From these data, it was concluded that OO-and SO-based IDPNs similarly improved nutritional status and influenced plasma lipid, oxidative, inflammatory and immune parameters.
Intravenous lipid emulsions in the critically ill: an update
Current Opinion in Critical Care, 2016
Purpose of review Purpose of the review is to summarize recent research addressing the role of intravenous lipid emulsions (IVLEs) in the critically ill. Recent findings Soybean oil-based IVLEs, which are high in the omega-6 polyunsaturated fatty acids, have been largely used in parenteral nutrition over the last several decades. However, it is now generally accepted that the higher content of phytosterols and polyunsaturated fatty acids in soybean oil IVLE may adversely affect the immunological and inflammatory status of the critically ill. In the last few years, alternative IVLEs with lower soybean oil content have been associated with important improvements in clinical outcomes, such as mortality, mechanical ventilation days, and ICU length of stay. Olive oil and fish oil IVLEs have been reported to reduce the incidence of infections, with no clear benefits in other clinical outcomes. Despite the promising results with these new parenteral nutrition strategies, the optimum compos...
Annals of Surgical Treatment and Research, 2016
This study was designed to investigate the effects of total parenteral nutrition (PN) using different lipid emulsions in patients undergoing major abdominal surgery. Methods: Fifty-two patients were randomized to receive soybean oil + medium chain triglycerides (MCT) (group I), soybean oil + olive oil (group II), soybean oil + olive oil + fish oil (group III) as a lipid source. PN was started on postoperative day 1 and patients were maintained on PN for a minimum period of 4 days. Laboratory variables (CRP, prealbumin, transferrin) were measured before surgery and on postoperative days. Results: Three treatment groups were included in the study. Patients in group I received long chain triglycerides (LCT) + LCT/MCT emulsion (%75 LCT + %25 LCT/MCT); Patients in group II received olive oil based emulsion (80% olive oil + 20% soybean oil, ClinOleic); Patients in group III received fish oil in addition to olive oil based emulsion (%85 ClinOleic + %15 Omegaven; Fresenius Kabi). The following 14 parameters were assessed: body weight, CRP, prealbumin, transferrin, tumor necrosis factor-α, interleukin-6, total antioxidant status, thiobarbituric acid reactive substances, oxidized low density lipoprotein-2, complete blood cell, international normalized ratio, D-dimer, activated partially thromboplastin time, prothrombin time. All other parameters showed no differences among the groups. Conclusion: The results of our trial demonstrate a potential beneficial effect of soybean oil/olive oil based lipid emulsions for use in PN regarding inflammatory response and oxidant capacity in the treatment of patients.