A.S.P.E.N. Clinical Guidelines

Background: Parenteral nutrition (PN) is a high‐alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence‐based policies, procedures, and practices. This document provides evidence‐based guidance for clinical practices involving PN prescribing, order review, and preparation. Method: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calcium‐phosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade (“premixed”) multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2‐in‐1 compared with 3‐in‐1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3‐in‐1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na‐ or K‐) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non‐nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient‐specific volumes are safe? (12) What beyond‐use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE?     

A.S.P.E.N. Clinical Guidelines

Background: Due to the high prevalence of obesity in adults, nutrition support clinicians are encountering greater numbers of obese patients who require nutrition support during hospitalization. The purpose of this clinical guideline is to serve as a framework for the nutrition support care of adult patients with obesity. Method: A systematic review of the best available evidence to answer a series of questions regarding management of nutrition support in patients with obesity was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development and Evaluation working group. A consensus process, that includes consideration of the strength of the evidence together with the risks and benefits to the patient, was used to develop the clinical guideline recommendations prior to multiple levels of external and internal review and approval by the A.S.P.E.N. Board of Directors. Questions: (1) Do clinical outcomes vary across levels of obesity in critically ill or hospitalized non?intensive care unit (ICU) patients? (2) How should energy requirements be determined in obese critically ill or hospitalized non‐ICU patients? (3) Are clinical outcomes improved with hypocaloric, high protein diets in hospitalized patients? (4) In obese patients who have had a malabsorptive or restrictive surgical procedure, what micronutrients should be evaluated?     

A.S.P.E.N. Clinical Guidelines

Background: Children with severe intestinal failure and prolonged dependence on parenteral nutrition are susceptible to the development of parenteral nutrition–associated liver disease (PNALD). The purpose of this clinical guideline is to develop recommendations for the care of children with PN‐dependent intestinal failure that have the potential to prevent PNALD or improve its treatment. Method: A systematic review of the best available evidence to answer a series of questions regarding clinical management of children with intestinal failure receiving parenteral or enteral nutrition was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group. A consensus process was used to develop the clinical guideline recommendations prior to external and internal review and approval by the American Society for Parenteral and Enteral Nutrition Board of Directors. Questions: (1) Is ethanol lock effective in preventing bloodstream infection and catheter removal in children at risk of PNALD? (2) What fat emulsion strategies can be used in pediatric patients with intestinal failure to reduce the risk of or treat PNALD? (3) Can enteral ursodeoxycholic acid improve the treatment of PNALD in pediatric patients with intestinal failure? (4) Are PNALD outcomes improved when patients are managed by a multidisciplinary intestinal rehabilitation team?     

A.S.P.E.N. Clinical Guidelines

Background: Premature infants are at increased risk for metabolic bone disease, with resulting delayed bone growth, osteopenia, and rickets. Method: A systematic review of the best available evidence to answer a series of questions regarding neonatal patients at risk of metabolic bone disease receiving parenteral or enteral nutrition was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development and Evaluation working group. A consensus process was used to develop the clinical guideline recommendations prior to external and internal review and approval by the American Society for Parenteral and Enteral Nutrition Board of Directors. Questions: (1) What maternal risk factors predispose the neonate to metabolic bone disease? (2) What is the optimal type of feeding to promote neonatal bone health? (3) When and how should vitamin D supplements be administered? (4) Does parenteral nutrition (PN) predispose a neonate to metabolic bone disease, and if so, are there PN formulation recommendations to minimize this risk?     

2005 American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Standards and Guidelines survey.

An online survey about the use and format of the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Standards and Guidelines documents was conducted. The survey was sent to A.S.P.E.N. members, and an acceptable number of responses were received (470, or 9% of those surveyed). Most respondents indicated an overall satisfaction with the standards and guidelines and suggested format changes, many of which will be incorporated into future guidelines and standards. The results of this survey are presented here for general interest. Changes in the process with which A.S.P.E.N. produces standards and guidelines are discussed.     

A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions

The currently available, standard soybean oil (SO)-based intravenous fat emulsions (IVFEs) meet the needs of most parenteral nutrition (PN) patients. There are alternative oil-based fat emulsions, such as medium-chain triglycerides (MCTs), olive oils (OOs), and fish oils (FOs), that, based on extensive usage in Europe, have an equivalent safety profile to SO. These alternative IVFEs are metabolized via different pathways, which may lead to less proinflammatory effects and less immune suppression. These alternative oil-based IVFEs are not currently available in the United States. Many patients who require IVFEs are already in a compromised state. Such patients could potentially have better clinical outcomes when receiving one of the alternative IVFEs to diminish the intake of the potentially proinflammatory ω-6 fatty acid-linoleic acid-which comprises more than 50% of the fatty acid profile in SO. Further research is needed on these alternative oil-based IVFEs to identify which IVFE oils or which combination of oils may be most clinically useful for specific patient populations.     

A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations

Parenteral nutrition (PN) serves as an important therapeutic modality that is used in adults, children, and infants for a variety of indications. The appropriate use of this complex therapy aims to maximize clinical benefit while minimizing the potential risks for adverse events. Complications can occur as a result of the therapy and as the result of the PN process. These consensus recommendations are based on practices that are generally accepted to minimize errors with PN therapy, categorized in the areas of PN prescribing, order review and verification, compounding, and administration. These recommendations should be used in conjunction with other A.S.P.E.N. publications, and researchers should consider studying the questions brought forth in this document.     

Proceedings of the 2014 A.S.P.E.N. Research Workshop

The human and earth microbiomes are among the most important biological agents in understanding and preventing disease. Technology is advancing at a fast pace and allowing for high‐resolution analysis of the composition and function of our microbial partners across regions, space, and time. Bioinformaticists and biostatisticians are developing ever more elegant displays to understand the generated megadatasets. A virtual cyberinfrastructure of search engines to cross‐reference the rapidly developing data is emerging in line with technologic advances. Nutrition science will reap the benefits of this new field, and its role in preserving the earth and the humans who inhabit it will become evidently clear. In this report we highlight some of the topics of an A.S.P.E.N.‐sponsored symposium held during Clinical Nutrition Week in 2013 that address the importance of the human microbiome to human health and disease.     

Proceedings From FDA/A.S.P.E.N. Public Workshop

The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean‐based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States.