Faculty Bibliography

BACKGROUND:The 2018 Lipids in Parenteral Nutrition summit involved a panel of experts in clinical nutrition, lipid metabolism, and pharmacology, to assess the current state of knowledge and develop expert consensus statements regarding the use of intravenous lipid emulsions in various patient populations and clinical settings. The main purpose of the consensus statements is to assist healthcare professionals by providing practical guidance on common clinical questions related to the provision of lipid emulsions as part of parenteral nutrition (PN). METHODS:The summit was designed to allow interactive discussion and consensus development. The resulting consensus statements represent the collective opinion of the members of the expert panel, which was informed and supported by scientific evidence and clinical experience. RESULTS:The current article summarizes the key discussion topics from the summit and provides a set of consensus statements designed to complement existing evidence-based guidelines. Lipid emulsions are a major component of PN, serving as a condensed source of energy and essential fatty acids. In addition, lipids modulate a variety of biologic functions, including inflammatory and immune responses, coagulation, and cell signaling. A growing body of evidence suggests that lipid emulsions containing ω-3 fatty acids from fish oil confer important clinical benefits via suppression of inflammatory mediators and activation of pathways involved in the resolution of inflammation. CONCLUSIONS:This article provides a set of expert consensus statements to complement formal PN guideline recommendations.

The inclusion of ω-3 fatty acids as part of parenteral nutrition is associated with clinical benefits such as a reduced likelihood of infectious complications and shorter hospital and intensive care unit (ICU) stays. As healthcare resources are limited, pharmacoeconomic analyses have been performed, typically modeling studies, using cost and outcomes data to investigate the cost-effectiveness of parenteral nutrition regimens including ω-3 fatty acids from fish oil compared with standard parenteral nutrition without such ω-3 fatty acids. This review covers pharmacoeconomic studies encompassing Italian, French, German, and UK hospitals for ICU and non-ICU hospitalized patients, and for ICU patients in China. The results show that the use of parenteral nutrition including ω-3 fatty acids more than offsets any additional acquisition costs in all national scenarios investigated to date, indicating that parenteral nutrition including ω-3 fatty acids is a clinically and economically beneficial strategy compared with standard parenteral nutrition.

BACKGROUND & AIMS:Intestinal failure (IF) is defined from a requirement or intravenous supplementation due to failing capacity to absorb nutrients and fluids. Acute IF is an acute, potentially reversible form of IF. We aimed to identify the prevalence, underlying causes and outcomes of acute IF. METHODS:This point-of-prevalence study included all adult patients hospitalized in acute care hospitals and receiving parenteral nutrition (PN) on a study day. The reason for PN and the mechanism of IF (if present) were documented by local investigators and reviewed by an expert panel. RESULTS:Twenty-three hospitals (19 university, 4 regional) with a total capacity of 16,356 acute care beds and 1237 intensive care unit (ICU) beds participated in this study. On the study day, 338 patients received PN (21 patients/1000 acute care beds) and 206 (13/1000) were categorized as acute IF. The categorization of reason for PN was revised in 64 cases (18.9% of total) in consensus between the expert panel and investigators. Hospital mortality of all study patients was 21.5%; the median hospital stay was 36 days. Patients with acute IF had a hospital mortality of 20.5% and median hospital stay of 38 days (P > 0.05 for both outcomes). Disordered gut motility (e.g. ileus) was the most common mechanism of acute IF, and 71.5% of patients with acute IF had undergone abdominal surgery. Duration of PN of ≥42 days was identified as being the best cut-off predicting hospital mortality within 90 days. PN ≥ 42 days, age, sepsis and ICU admission were independently associated with 90-day hospital mortality. CONCLUSIONS:Around 2% of adult patients in acute care hospitals received PN, 60% of them due to acute IF. High 90-day hospital mortality and long hospital stay were observed in patients receiving PN, whereas presence of acute IF did not additionally influence these outcomes. Duration of PN was associated with increased 90-day hospital mortality.

This systematic review and meta-analysis investigated ω-3 fatty-acid enriched parenteral nutrition (PN) vs standard (non-ω-3 fatty-acid enriched) PN in adult hospitalized patients (PROSPERO 2018 CRD42018110179). We included 49 randomized controlled trials (RCTs) with intervention and control groups given ω-3 fatty acids and standard lipid emulsions, respectively, as part of PN covering ≥70% energy provision. The relative risk (RR) of infection (primary outcome; 24 RCTs) was 40% lower with ω-3 fatty-acid enriched PN than standard PN (RR 0.60, 95% confidence interval [CI] 0.49-0.72; P < 0.00001). Patients given ω-3 fatty-acid enriched PN had reduced mean length of intensive care unit (ICU) stay (10 RCTs; 1.95 days, 95% CI 0.42-3.49; P = 0.01) and reduced length of hospital stay (26 RCTs; 2.14 days, 95% CI 1.36-2.93; P < 0.00001). Risk of sepsis (9 RCTs) was reduced by 56% in those given ω-3 fatty-acid enriched PN (RR 0.44, 95% CI 0.28-0.70; P = 0.0004). Mortality rate (co-primary outcome; 20 RCTs) showed a nonsignificant 16% reduction (RR 0.84, 95% CI 0.65-1.07; P = 0.15) for the ω-3 fatty-acid enriched group. In summary, ω-3 fatty-acid enriched PN is beneficial, reducing risk of infection and sepsis by 40% and 56%, respectively, and length of both ICU and hospital stay by about 2 days. Provision of ω-3-enriched lipid emulsions should be preferred over standard lipid emulsions in patients with an indication for PN.

BACKGROUND:Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. METHODS/DESIGN/METHODS:The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. DISCUSSION/CONCLUSIONS:Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

BACKGROUND & AIMS:in a multinational sample of adult patients; to provide a description of QOL dimensions by short and long HPN treatment duration; to explore clinical factors potentially associated to QOL scores. METHODS:. The questionnaires were analysed to evaluate data completeness, convergent/discriminant validity and internal-consistency reliability. The association of overall QOL and HPN treatment duration as well as other clinical factors were investigated using multivariable linear regression models. RESULTS:in the different English, French and Italian language patient sub-groups confirmed psychometric equivalence of the three questionnaire versions. The results of the multivariable linear regression showed that QOL scores were significantly associated with HPN duration (better in long-term), underlying disease (better in Crohn's disease and mesenteric ischaemia) and living status (worse in living alone) and, after adjusting for the other factors, with the number of days of HPN infusion per week. CONCLUSIONS:, is a valid tool for measurement of QOL in patients on HPN, to be used in the clinical practice as well as in research.

In chronic kidney disease (CKD), the design of the parenteral nutrition (PN) regimen becomes more challenging where only individualized PN is appropriate, coupled with the increased risk of unintended interactions with diuretic therapy. In an effort to ensure safe therapy in the home, we assessed the physical stability of bespoke PN formulations intended for use in CKD in the simultaneous presence of Y-site compatibility of furosemide and torasemide. The patient's daily needs were determined based on both metabolic demands as well as the demand for fluids.Complete admixtures were subjected to physical stability analysis consisting of visual inspection, a validated light microscope method, pH measurement, zeta potential measurement, and characterization of oily globule size distribution. Y-site compatibility of furosemide and torasemide with the formulated admixtures was also performed.The total parenteral admixture was stable over 7 days at +4°C and 24 h at +25°C and compatible via the Y-line together with furosemide and torasemide over 12 h at +25°C.The stability assessment guarantees the safety and efficiency of home PN with loop diuretics therapy in CKD patients. This means that these patients do not need long hospitalization and they can be safely treated at home. Furthermore, this study proved that torasemide is the same safety diuretic as furosemide, which has a great impact on clinical practice.