Advances in Trace Element Supplementation for Parenteral Nutrition.

Parenteral nutrition (PN) provides support for patients lacking sufficient intestinal absorption of nutrients. Historically, the need for trace element (TE) supplementation was poorly appreciated, and multi-TE products were not initially subjected to rigorous oversight by the United States Food and Drug Administration (FDA). Subsequently, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued dosage recommendations for PN, which are updated periodically. The FDA has implemented review and approval processes to ensure access to safer and more effective TE products. The development of a multi-TE product meeting ASPEN recommendations and FDA requirements is the result of a partnership between the FDA, industry, and clinicians with expertise in PN. This article examines the rationale for the development of TRALEMENT® (Trace Elements Injection 4*) and the FDA's rigorous requirements leading to its review and approval. This combination product contains copper, manganese, selenium, and zinc and is indicated for use in adults and pediatric patients weighing ≥10 kg. Comprehensive management of PN therapy requires consideration of many factors when prescribing, reviewing, preparing, and administering PN, as well as monitoring the nutritional status of patients receiving PN. Understanding patients' TE requirements and incorporating them into PN is an important part of contemporary PN therapy.

Association between protein intake and lean body mass in a group of Masters Athletes.

Recommendations for protein intake are based on total body weight; however, these recommendations do not consider lean body mass (LBM). The purpose of the present study was to identify the average protein intake in g/kg LBM in a group of healthy Masters Athletes (≥26 years of age, exercising ≥2 d/week). Data were obtained from a cross-sectional study. Body weight (kg), height (cm) and LBM via dual-energy X-ray absorptiometry were measured. Dietary intake was measured using a 2005 Block Food Frequency Questionnaire. The average energy intake, the percent energy from protein and the average protein intake in g/kg LBM were calculated. Differences between protein intake and the US Recommended Dietary Allowance (US RDA) (0⋅8 g/kg body weight) were determined. Alpha levels were set a priori to P < 0⋅05. A total of 176 participants (94 women, 82 men; 39 ± 11 years of age; body mass index: 24⋅6 ± 3⋅4 kg/m2) were analysed. The average energy intake, the percent protein energy and the average protein intake were 7996⋅9 ± 110⋅9 kilojoules (kJ)/d (1,910⋅4 ± 26⋅5 kcal), 15⋅5 ± 2⋅6 % and 1⋅43 ± 0⋅53 g/kg LBM, respectively. No differences existed between women and men for protein intake/kg LBM. Both sexes had significantly higher protein intakes than the US RDA (P < 0⋅001). We identified the average protein intake (g/kg LBM) in healthy Masters Athletes that may contribute to evolving perspectives on the determination of protein needs. The present study helps establish the relationship between protein intake and LBM so that we may further increase our accuracy when developing future protein recommendations.

The Value of Nutrition Support Pharmacist Interventions.

The PHarmacist Avoidance or Reductions in Medical Costs in CRITically Ill Adults: PHARM-CRIT Study by Rech et al demonstrated the value of critical care pharmacists' interventions. The services provided by nutrition support pharmacists were briefly mentioned. This article aims to highlight the value of interventions provided by nutrition support pharmacists.

Parenteral nutrition compatibility and stability: A comprehensive review.

Several guidance documents support best practices across the stages of the parenteral nutrition (PN) use process to optimize patient safety. The critical step of PN order verification and review by the pharmacist requires a contextual assessment of the compatibility and stability implications of the ordered PN prescription. This article will provide working definitions, describe PN component characteristics, and present a wide-ranging representation of compatibility and stability concerns that need to be considered prior to preparing a PN admixture. This paper has been approved by the American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors.

Enteral Medication for the Tube-Fed Patient: Making This Route Safe and Effective.

The administration of medication through an enteral access device requires important forethought. Meeting a patient's therapeutic needs requires achieving expected drug bioavailability without increasing the risk for toxicity, therapeutic failure, or feeding tube occlusion. Superimposing gut dysfunction, critical illness, or enteral nutrition-drug interaction further increases the need for a systematic approach to prescribing, evaluating, and preparing a drug for administration through an enteral access device. This review will explain the fundamental factors involved in drug bioavailability through the gut, address the influencing considerations for the enterally fed patient, and describe best practices for enteral drug preparation and administration.

Summary of Proceedings and Expert Consensus Statements From the International Summit "Lipids in Parenteral Nutrition".

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.

Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects.

A number of topics important to the handling of intravenous lipid emulsions (ILEs) were discussed at the international summit. ILE handling includes the preparation and the administration steps in the typical use of parenteral nutrition (PN). The discussion and consensus statements addressed several issues, including standardization of the PN process, use of commercially available multi-chamber PN or compounded PN bags, the supervision by a pharmacist with expertise, limiting ILE repackaging, and infusion duration.

Hemofilter Obstruction with Intravenous Lipid Administration.

A critically ill patient requiring continuous venovenous hemofiltration therapy received parenteral nutrition through the same commonly used intravascular device. The inclusion of injectable lipid emulsion had an adverse effect on hemofilter function. This was successfully managed first by using lipid-free parenteral nutrition and then by administering the total nutrient admixture via a separate central venous access device.

Drug-Nutrition Interactions and the Brain: It's Not All in Your Head.

PURPOSE OF REVIEW: The interactions between nutrition and medication can be numerous with potential impact on health outcomes. Several subtypes of drug-nutrition interactions exist. Each of these interaction subtypes may influence patients receiving medication for neurologic disorders. After defining drug-nutrition interactions, this review will describe the various types using a handful of widely used central nervous system agents as examples. RECENT FINDINGS: Medication may be the object of interactions perpetrated by a specific meal, a food component, a nutrient, or nutrition status thereby altering drug disposition and clinical effect. On the other hand, drugs can influence nutrition status generally or the status of specific nutrients by any number of mechanisms. Individuals using medication for neurologic disorders are at risk for drug-nutrition interactions of all types.

Serum 25OHD concentration as a predictor of haemoglobin A1c among adults living in the USA: NHANES 2003 to 2010.

BACKGROUND: Vitamin D status influences glucose metabolism. Serum 25-hydroxyvitamin D (25OHD) concentrations have been inversely associated with type 2 diabetes risk. The optimal serum 25OHD level needed for adequate glycaemic control is unknown. OBJECTIVE: To determine the relationship among serum 25OHD concentrations and degree of glucose regulation using percentage of haemoglobin A1c (HbA1c%). METHODS: Data for adults ≥ 20 years from the National Health and Nutrition Examination Survey (NHANES) (2003-2010) were included. A binary logistic regression was used for serum 25OHD (nmol/L) as a continuous variable to determine the OR and 95% CI for HbA1c >6.5%, adjusting for sex, race and body mass index (BMI). Measures of serum 25OHD were grouped into quartiles and entered into a binary logistic regression model to determine the OR and 95% CI for HbA1c >6.5% in an adjusted model. RESULTS: Across all NHANES cycles, lower serum 25OHD was associated with greater odds of HbA1c ≥ 6.5% when adjusting for sex, race, age and BMI (NHANES 2003-2004 (N=4402): OR 0.985, 95% CI 0.979 to 0.990; NHANES 2005-2006 (N=4409): OR 0.976, 95% CI 0.969 to 0.982; NHANES 2007-2008 (N=4525): OR 0.989, 95% CI 0.984 to 0.993; and NHANES 2009-2010 (N=5660): OR 0.988, 95% CI 0.984 to 0.991). In an adjusted model, the lowest quartile of serum 25OHD (0-41 nmol/L, N=4879) was associated with greater odds of HbA1c ≥ 6.5% compared with the highest quartile (73-260 nmol/L, N=4472), OR 2.37, 95% CI 2.03 to 2.77. The odds of HbA1c ≥ 6.5% were also greater for adults with serum 25OHD considered to be sufficient compared with the highest quartile, OR 1.68, 95% CI 1.56 to 1.61). CONCLUSION: Lower serum 25OHD concentrations are associated with poor glycaemic control (HbA1c ≥ 6.5%). Sufficient serum 25OHD levels were also associated with poorer blood glucose control. Further research is needed to investigate an optimal serum concentration or threshold to support adequate blood glucose control.

Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.

BACKGROUND: Patients with intestinal failure associated with short bowel syndrome (SBS-IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS-IF in the randomized, placebo (PBO)-controlled STEPS study (NCT00798967) and its 2-year, open-label extension, STEPS-2 (NCT00930644). METHODS: STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day). Baseline was the start of TED treatment, in either STEPS or STEPS-2. At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months. RESULTS: Fourteen patients enrolled (TED-TED, n = 5; NT/PBO-TED, n = 9) and 13 completed STEPS-3. At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively. Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively. Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS-2 maintained enteral autonomy throughout STEPS-3. All patients reported ≥1 treatment-emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related. No patient had a treatment-related treatment-emergent serious AE. CONCLUSIONS: Long-term TED treatment yielded a safety profile consistent with previous studies, sustained efficacy, and a further decline in PS requirements.

Standardized Competencies for Parenteral Nutrition Administration: The ASPEN Model.

Parenteral nutrition (PN) is a highly complex medication and its provision can be prone to a variety of errors. Safe administration of this therapy requires that the competency of clinicians, particularly nurses, be demonstrated using a standardized process. In this document, a standardized model for PN administration competency is proposed based on a competency framework, the ASPEN-published interdisciplinary core competencies, discipline-specific standards of practice, safe practice recommendations, and clinical guidelines. ASPEN recognizes that all healthcare institutions may not currently meet the aspirational goals of this document. This framework will guide institutions and agencies in developing tools and procedures and maintaining competency of staff members around safe PN administration. The ASPEN Board of Directors has approved this document.

Lipid Injectable Emulsions: Infusion Confusion.

The commentary addresses discussion regarding the duration of infusion for lipid injectable emulsions (ILEs; previously known as intravenous fat emulsion) when administered separately from amino acids and dextrose (2:1) admixtures. The article by Mundi et al describes the administration time of ILEs administered separately as up to 24 hours, while previous American Society for Parenteral and Enteral Nutrition documents have outlined the infusion time not to exceed 12 hours.

Lipid Injectable Emulsion Survey With Gap Analysis.

BACKGROUND: Lipid injectable emulsion (ILE) is an integral part of parenteral nutrition (PN), providing energy and essential fatty acids. With recent consensus recommendations for PN, clinical guidelines for ordering and preparation of PN, the U.S. Food and Drug Administration approval of new ILE products, and revised ILE labeling to include a 1.2-micron filter, a gap in current practice knowledge was apparent. MATERIALS AND METHODS: The American Society for Parenteral and Enteral Nutrition PN Safety Committee surveyed clinicians on how ILE products are prescribed, prepared, and administered to patients from neonates to adults. RESULTS: The results of this survey conducted in late 2016 found a wide variation in practice, particularly across patient age groups. CONCLUSION: These findings demonstrate the need for ongoing dissemination and education on standardized safe practices for ILE use.

Parenteral Nutrition Errors and Potential Errors Reported Over the Past 10 Years.

Parenteral nutrition (PN) is a complex, high-alert medication, and errors associated with the use of this therapy may lead to significant harm to patients. This document reviews error reports from the Institute for Safe Medication Practices' Medication Errors Reporting Program that are associated with the PN use process over the past 10 years. Actual PN-related errors are outlined, with most occurring in the PN-compounding/dispensing and PN administration steps. Clinicians involved in any phase of the PN use process should review their institutional or homecare company's processes for reporting of PN errors and collaborate with their medical safety officer and/or committees involved with medication error reporting.

Evaluation of Lean Body Weight Equation by Dual-Energy X-Ray Absorptiometry Measures.

BACKGROUND: When managing patients with disorders that require clinical intervention, a practical assessment of body habitus is valued. The Duffull-Green lean body weight (LBW) equation was derived and validated in adults across a wide body mass index (BMI) range. Whether this predictive equation will perform well in patients at BMI extremes or perform better than a widely used empiric "ideal" body weight (IBW) equation is unknown. MATERIALS AND METHODS: Calculated LBW and calculated IBW were each compared with the dual-energy x-ray absorptiometry (DXA)-derived lean body mass (LBM) by simple linear regression. A mixed model was used to determine how well the LBW equation performed over time in patients with more than 1 DXA measurement. RESULTS: At time 0, 32 patients were 18-67 years old, and all were obese (BMI: 36-65 kg/m2), while the remaining 7 had parenteral nutrition-dependent intestinal failure (BMI: 17-25 kg/m2). A subset of patients underwent bariatric surgery after time 0 (BMI at follow-up: 22-49 kg/m2). The LBW equation was a predictor of LBM ( R2 = 0.67, P < .0001), while the IBW equation was not ( R2 = 0.04, P = .25). The LBW equation remained a predictor of LBM over time ( P < .0001) without significant interaction by number of months since time 0. CONCLUSION: The Duffull-Green LBW equation successfully predicted lean body mass in a patient population with a wide range of BMIs at both a single point in time and after considerable weight loss. In the clinical setting, an equation that performs well in various disease states and body sizes is advantageous.

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome.

BACKGROUND: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. MATERIALS AND METHODS: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. RESULTS: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. CONCLUSION: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence.

ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text].

Enteral nutrition (EN) is a valuable clinical intervention for patients of all ages in a variety of care settings. Along with its many outcome benefits come the potential for adverse effects. These safety issues are the result of clinical complications and of process-related errors. The latter can occur at any step from patient assessment, prescribing, and order review, to product selection, labeling, and administration. To maximize the benefits of EN while minimizing adverse events requires that a systematic approach of care be in place. This includes open communication, standardization, and incorporation of best practices into the EN process. This document provides recommendations based on the available evidence and expert consensus for safe practices, across each step of the process, for all those involved in caring for patients receiving EN.