Expert consensus statements and summary of proceedings from the International Safety and Quality of Parenteral Nutrition Summit.

PURPOSE: The International Safety and Quality of Parenteral Nutrition (PN) Summit consisted of presentations, discussions, and formulation of consensus statements. The purpose here is to briefly summarize the summit and to present the consensus statements. SUMMARY: There was a high degree of consensus, with all statements approved by all authors/summit experts. These consensus statements should be regarded not as formal guidelines but rather as best-practice guidance intended to complement national and international nutrition society evidence-based guidelines and position statements. This article also summarizes key discussion topics from the summit, encompassing up-to-date knowledge and practical guidance concerning PN safety and quality in various countries and clinical settings, focusing on adult patients. Clear geographical differences exist between practices in Europe and the United States, and different approaches to improve the safety, quality, and cost-effectiveness of PN vary, particularly with regard to the delivery systems used. Discussion between experts allowed for an exchange of practical experience in optimizing PN use processes, opportunities for standardization, use of electronic systems, potential improvements in PN formulations, better management during PN component shortages, and practical guidance to address patients' needs, particularly during long-term/home PN. CONCLUSION: The consensus statements are the collective opinion of the panel members and form best-practice guidance. The authors intend that this guidance may help to improve the safety and quality of PN in a variety of settings by bridging the gap between published guideline recommendations and common practical issues.

Parenteral nutrition in clinical practice: International challenges and strategies.

PURPOSE: Parenteral nutrition (PN) is an established therapy when oral/enteral feeding is not sufficient or is contraindicated, but nevertheless PN remains a complex, high-alert medication that is susceptible to errors that may affect patient safety. Over time, considerable progress has been made to make PN practices safer. The purpose of this article is to address ongoing challenges to improve the PN use process from prescription to administration and monitoring, and to outline practical aspects fostering the safety, quality, and cost-effectiveness of PN, as discussed at the International Safety and Quality of PN Summit. SUMMARY: Opportunities to improve the PN use process in clinical practice include the promotion of inter-disciplinary communication, vigilant surveillance for complications, staff education to increase competency, and more consistent use of advanced technologies that allow automated safety checks throughout the PN process. Topics covered include considerations on PN formulations, including the value of intravenous lipid emulsions (ILEs), trends in compounding PN, the current and future role of market-authorized multi-chamber PN bags containing all 3 macronutrients (amino acids, glucose/dextrose, and ILE) in the United States and in Europe, and strategies to cope with the increasing global problem of PN product shortages. CONCLUSION: This review outlines potential strategies to use in clinical practice to overcome ongoing challenges throughout the PN use process, and ultimately promote PN patient safety.

Parenteral nutrition in the hospital setting/short-term parenteral nutrition.

PURPOSE: This article is based on presentations and discussions held at the International Safety and Quality of Parenteral Nutrition (PN) Summit concerning the acute care setting. Some European practices presented in this article do not conform with USP general chapter <797> requirements. Nevertheless, the purpose is to cover the challenges experienced in delivering high-quality PN within hospitals in the United States and Europe, in order to share best practices and experiences more widely. SUMMARY: Core issues regarding the PN process within an acute care setting are largely the same everywhere: There are ongoing pressures for greater efficiency, optimization, and also concurrent commitments to make PN safer for patients. Within Europe, in recent years, the use of market-authorized multi-chamber bags (MCBs) has increased greatly, mainly for safety, cost-effectiveness, and efficiency purposes. However, in the US, hospitals with low PN volumes may face particular challenges, as automated compounding equipment is often unaffordable in this setting and the variety of available MCBs is limited. This can result in the need to operate several PN systems in parallel, adding to the complexity of the PN use process. Ongoing PN quality and safety initiatives from US institutions with various PN volumes are presented. In the future, the availability of a greater selection of MCBs in the US may increase, leading to a reduction in dependence on compounded PN, as has been seen in many European countries. CONCLUSION: The examples presented may encourage improvements in the safety and quality of PN within the acute care setting worldwide.

Comparing Aluminum Concentrations in Adult and Pediatric Parenteral Nutrition Solutions: Multichamber-Bag versus Compounded Parenteral Nutrition.

Aluminum contamination in parenteral nutrition (PN) solutions can lead to neurotoxicity, reduced bone mass, and liver toxicity, especially in pediatric patients. Ingredients commonly used in PN compounding, such as vitamins, trace elements, calcium, and phosphate salts, contain significant amounts of aluminum. This study aimed to compare aluminum concentrations in multichamber-bag (MCB) and compounded PN for adults and pediatrics. A prospective study assessed aluminum concentrations in various types of MCB and compared them with compounded PN formulations with similar compositions. The types of MCB included Lipoflex® (without electrolytes), Omegaflex®, Finomel®, Smofkabiven® (with and without electrolytes), Olimel®, Clinimix®, and Numeta®. Overall, 80 aluminum determinations were included: 36 for MCBs and 44 for compounded PN. MCBs showed significantly lower aluminum concentrations than compounded PN: 11.37 (SD 6.16) vs. 21.45 (8.08) µg/L, respectively. Similar results were observed for adult (n = 40) and pediatric (n = 40) PN formulations (12.97 (7.74) vs. 20.78 (10.28) µg/L, and 9.38 (2.23) vs. 22.01 (5.82) µg/L, respectively). Significant differences were also found between MCBs depending on the manufacturing company. These findings suggest that MCBs PN offer a safer option for reducing aluminum contamination in PN. Harmonizing regulations concerning aluminum concentrations in PN solutions could help mitigate differences between PN formulations.

Long-term effect of tocilizumab on mortality, readmissions, persistent symptoms and lung function in SARS-CoV-2 patients 1 year after hospital discharge: A matched cohort study.

BACKGROUND: Tocilizumab is presumed to be an effective and safe treatment for severe SARS-Cov-2, but its usefulness has not been investigated yet for long-term outcomes. This study aimed to evaluate the influence of tocilizumab on mortality in patients with SARS-CoV-2 throughout the year following discharge. METHODS: A retrospective observational analysis was performed on electronic medical records of patients with SARS-CoV2 who were discharged from our hospital after surviving the first wave in March-April 2020. Logistic regression was used to analyse the effect of tocilizumab on mortality, as the main outcome, and propensity-score analysis to further validate their effect. Secondary outcomes were readmissions, persistent symptoms and lung function evolution. Patients were selected by matching their individual propensity for receiving therapy with tocilizumab, conditional on their demographic and clinical variables. RESULTS: A total of 405 patients were included in the mortality study (33.6 % were treated with tocilizumab) and 390 were included in the assessment of persistent symptoms. After propensity-score analysis, no association between tocilizumab use and 1-year overall mortality was found (HR= 2.05, 95 % CI: 0.21-19.98). No differences regarding persistent symptoms (OR= 1.01 95 %CI 0.57-1.79), nor lung function parameters (forced vital capacity: coefficient -0.16 95 %CI -0.45 to 0.14) were found throughout the year follow-up between control and tocilizumab group. CONCLUSIONS: The administration of tocilizumab in patients with SARS-CoV-2 did not show any effect on long-term mortality. Identically, no association were found regarding readmissions, persistent symptoms or lung function evolution and tocilizumab administration in our cohort of patients after 1 year follow-up.

Aluminum blood concentration in adult patients: effect of multichamber-bag versus hospital-compounded parenteral nutrition / Concentración sanguínea de aluminio en pacientes adultos: efecto de la nutrición parenteral tricameral frente a la nutrición parenteral elaborada en el hospital

Background: the administration of aluminum-contaminated parenteral nutrition (PN) leads to an accumulation of aluminum. The aim of this study was to assess blood aluminum concentrations (BACs) of inpatients receiving multichamber-bag (MCB) PN compared to those receiving compounded PN. Methods: available BACs were retrospectively gathered from patient charts of adult inpatients receiving PN from 2015 to 2020, and compared depending on the type of PN administered. Long-term PN patients, defined as ≥ 20 days of PN, receiving at least > 10 days of compounded PN, were compared to long-term patients receiving only MCB. Results: a total of 160 BACs were available from 110 patients. No differences were found according to type of PN (mean BAC: 3.11 ± 2.75 for MCB versus 3.58 ± 2.08 µg/L for compounded PN). Baseline total bilirubin, surgery and days with PN were related to higher BACs (coefficient: 0.30 [95 % CI, 0.18-0.42], 1.29 [95 % CI, 0.52-2.07], and 0.06 [95 % CI: 0.01-0.11], respectively). Regarding long-term PN, patients receiving only MCB (n = 21) showed lower BACs compared to the compounded PN (n = 17) [2.99 ± 1.55 versus 4.35 ± 2.17 µg/L, respectively; p < 0.05]. Conclusions: although there were no differences in BAC according to type of PN administered, in long-term PN, MCB PN was associated with lower BACs as compared to compounded PN. (AU)

Antecedentes: la administración de nutrición parenteral (NP) contaminada con aluminio conduce a su acumulación. El objetivo de este estudio fue evaluar las concentraciones de aluminio en sangre (CAS) en pacientes hospitalizados que recibieron NP elaboradas en el hospital o bolsas tricamerales. Métodos: se recogieron retrospectivamente las CAS disponibles de los pacientes hospitalizados con NP durante el período entre 2015 y 2020, comparándose los valores en función del tipo de NP administrada. Se comparan igualmente los valores de pacientes de larga duración, definida como ≥ 20 días de NP, que recibieron al menos > 10 días de NP elaborada frente aquellos de larga duración que recibieron solo NP tricameral. Resultados: se incluyeron un total de 160 CAS de 110 pacientes. No se encontraron diferencias con respecto al tipo de NP (CAS media: 3,11 ± 2,75 para la tricameral frente a 3,58 ± 2,08 µg/L para la elaborada). La bilirrubina total basal, la cirugía y los días con NP se relacionaron con un mayor valor de CAS (coeficiente: 0,30 [IC 95 %: 0,18-0,42], 1,29 [IC 95 %: 0,52-2,07] y 0,06 [IC 95 %: 0,01-0,11], respectivamente). En la NP a largo plazo, los pacientes que recibieron solo NP tricameral (n = 21) mostraron una CAS menor en comparación con el grupo que recibió al menos 10 NP elaboradas (n = 17) [2,99 ± 1,55 versus 4,35 ± 2,17 µg/L, respectivamente; p < 0,05]. Conclusiones: aunque no hubo diferencias de CAS con respecto al tipo de NP administrada, en la NP a largo plazo, la administración de NP tricameral se asoció con CAS menores en comparación con la NP elaborada. (AU)

Aluminum blood concentration in adult patients: effect of multichamber-bag versus hospital-compounded parenteral nutrition.

Introduction: Background: the administration of aluminum-contaminated parenteral nutrition (PN) leads to an accumulation of aluminum. The aim of this study was to assess blood aluminum concentrations (BACs) of inpatients receiving multichamber-bag (MCB) PN compared to those receiving compounded PN. Methods: available BACs were retrospectively gathered from patient charts of adult inpatients receiving PN from 2015 to 2020, and compared depending on the type of PN administered. Long-term PN patients, defined as ≥ 20 days of PN, receiving at least > 10 days of compounded PN, were compared to long-term patients receiving only MCB. Results: a total of 160 BACs were available from 110 patients. No differences were found according to type of PN (mean BAC: 3.11 ± 2.75 for MCB versus 3.58 ± 2.08 µg/L for compounded PN). Baseline total bilirubin, surgery and days with PN were related to higher BACs (coefficient: 0.30 [95 % CI, 0.18-0.42], 1.29 [95 % CI, 0.52-2.07], and 0.06 [95 % CI: 0.01-0.11], respectively). Regarding long-term PN, patients receiving only MCB (n = 21) showed lower BACs compared to the compounded PN (n = 17) [2.99 ± 1.55 versus 4.35 ± 2.17 µg/L, respectively; p < 0.05]. Conclusions: although there were no differences in BAC according to type of PN administered, in long-term PN, MCB PN was associated with lower BACs as compared to compounded PN.

Introducción: Antecedentes: la administración de nutrición parenteral (NP) contaminada con aluminio conduce a su acumulación. El objetivo de este estudio fue evaluar las concentraciones de aluminio en sangre (CAS) en pacientes hospitalizados que recibieron NP elaboradas en el hospital o bolsas tricamerales. Métodos: se recogieron retrospectivamente las CAS disponibles de los pacientes hospitalizados con NP durante el período entre 2015 y 2020, comparándose los valores en función del tipo de NP administrada. Se comparan igualmente los valores de pacientes de larga duración, definida como ≥ 20 días de NP, que recibieron al menos > 10 días de NP elaborada frente aquellos de larga duración que recibieron solo NP tricameral. Resultados: se incluyeron un total de 160 CAS de 110 pacientes. No se encontraron diferencias con respecto al tipo de NP (CAS media: 3,11 ± 2,75 para la tricameral frente a 3,58 ± 2,08 µg/L para la elaborada). La bilirrubina total basal, la cirugía y los días con NP se relacionaron con un mayor valor de CAS (coeficiente: 0,30 [IC 95 %: 0,18-0,42], 1,29 [IC 95 %: 0,52-2,07] y 0,06 [IC 95 %: 0,01-0,11], respectivamente). En la NP a largo plazo, los pacientes que recibieron solo NP tricameral (n = 21) mostraron una CAS menor en comparación con el grupo que recibió al menos 10 NP elaboradas (n = 17) [2,99 ± 1,55 versus 4,35 ± 2,17 µg/L, respectivamente; p < 0,05]. Conclusiones: aunque no hubo diferencias de CAS con respecto al tipo de NP administrada, en la NP a largo plazo, la administración de NP tricameral se asoció con CAS menores en comparación con la NP elaborada.

Parenteral Nutrition Overview.

Parenteral nutrition (PN) is a life-saving intervention for patients where oral or enteral nutrition (EN) cannot be achieved or is not acceptable. The essential components of PN are carbohydrates, lipids, amino acids, vitamins, trace elements, electrolytes and water. PN should be provided via a central line because of its hypertonicity. However, peripheral PN (with lower nutrient content and larger volume) can be administered via an appropriate non-central line. There are alternatives for the compounding process also, including hospital pharmacy compounded bags and commercial multichamber bags. PN is a costly therapy and has been associated with complications. Metabolic complications related to macro and micronutrient disturbances, such as hyperglycemia, hypertriglyceridemia, and electrolyte imbalance, may occur at any time during PN therapy, as well as infectious complications, mostly related to venous access. Long-term complications, such as hepatobiliary and bone disease are associated with longer PN therapy and home-PN. To prevent and mitigate potential complications, the optimal monitoring and early management of imbalances is required. PN should be prescribed for malnourished patients or high-risk patients with malnutrition where the feasibility of full EN is in question. Several factors should be considered when providing PN, including timing of initiation, clinical status, and risk of complications.

Effect of tocilizumab versus standard of care in adults hospitalized with moderate-severe COVID-19 pneumonia.

Introduction and objectives: Tocilizumab is an interleukin-6 receptor-blocking agent proposed for the treatment of severe COVID-19; however, limited data are available on their efficacy. The aim of this study was to assess the effect of tocilizumab on the outcomes of patients with COVID-19 pneumonia by using propensity-score-matching (PSM) analysis. Methods: A retrospective observational analysis of hospitalized COVID-19 adult patients admitted to the Vall d'Hebron Hospital was performed between March and April 2020. We used the logistic regression to analyze the effect of tocilizumab on mortality, as main outcome, and PSM analysis to further validate their effect. Secondary outcomes were length-of-stay (LOS) and intensive-care-unit (ICU) stay. Same outcomes were also assessed for early tocilizumab administration, within 72 h after admission. Patients were selected by matching their individual propensity for receiving therapy with tocilizumab, conditional on their demographic and clinical variables. Results: A total of 544 COVID-19 patients were included, 197 (36.2%) were treated with tocilizumab of whom 147 were treated within the first 72 h after admission; and 347 were included in the control group. After PSM analyses, the results showed no association between tocilizumab use and overall mortality (OR = 1.03, 95%CI: 0.63-1.68). However, shorter ICU-stay in the tocilizumab group was found compared to the control group (Coefficient -4.27 95%CI: -6.63 to -1.92). Similar results were found in the early tocilizumab cohort. Conclusions: The administration of tocilizumab in patients with moderate to severe COVID-19 did not reduce the risk of mortality in our cohort of patients, regardless of the time of administration.

Introducción y objetivos: El tocilizumab es un agente bloqueador del receptor de la interleucina 6 propuesto para el tratamiento de la COVID-19 grave; sin embargo, se dispone de datos limitados sobre su eficacia. El objetivo de este estudio fue evaluar el efecto de tocilizumab en los resultados de los pacientes con neumonía por COVID-19 mediante un análisis de emparejamiento por propensity-score-matching (PSM, «puntuación de propensión¼). Métodos: Se realizó un análisis observacional retrospectivo de los pacientes adultos con COVID-19 ingresados en el Hospital Vall d'Hebron entre marzo y abril de 2020. Se utilizó la regresión logística para analizar el efecto de tocilizumab en la mortalidad, como resultado principal, y el análisis PSM para validar aún más su efecto. Los resultados secundarios fueron la duración de la estancia y la estancia en la unidad de cuidados intensivos (UCI). También se evaluaron los mismos resultados para la administración temprana de tocilizumab, dentro de las 72 h posteriores al ingreso. Los pacientes se seleccionaron mediante el emparejamiento de su propensión individual a recibir tratamiento con tocilizumab, condicionado a sus variables demográficas y clínicas. Resultados: Se incluyeron 544 pacientes de COVID-19, 197 (36,2%) fueron tratados con tocilizumab, de los cuales 147 fueron tratados dentro de las primeras 72 h tras el ingreso; y 347 fueron incluidos en el grupo control. Tras los análisis PSM, los resultados no mostraron ninguna asociación entre el uso de tocilizumab y la mortalidad global (OR = 1,03; IC del 95%: 0,63-1,68). Sin embargo, se encontró una menor estancia en la UCI en el grupo de tocilizumab en comparación con el grupo de control (coeficiente −4,27; IC del 95%: −6,63 − −1,92). Se encontraron resultados similares en la cohorte de tocilizumab temprano. Conclusiones: La administración de tocilizumab en pacientes con COVID-19 moderada a grave no redujo el riesgo de mortalidad en nuestra cohorte de pacientes, independientemente del momento de la administración.

Effect of tocilizumab versus standard of care in adults hospitalized with moderate-severe COVID-19 pneumonia / Efecto de tocilizumab frente a cuidado estándar en pacientes adultos hospitalizados con neumonía COVID-19 moderada-grave

Introduction and objectives:Tocilizumab is an interleukin-6 receptor-blocking agent proposed for the treatment of severe COVID-19; however, limited data are available on their efficacy. The aim of this study was to assess the effect of tocilizumab on the outcomes of patients with COVID-19 pneumonia by using propensity-score-matching (PSM) analysis.Methods:A retrospective observational analysis of hospitalized COVID-19 adult patients admitted to the Vall d’Hebron Hospital was performed between March and April 2020. We used the logistic regression to analyze the effect of tocilizumab on mortality, as main outcome, and PSM analysis to further validate their effect. Secondary outcomes were length-of-stay (LOS) and intensive-care-unit (ICU) stay. Same outcomes were also assessed for early tocilizumab administration, within 72h after admission. Patients were selected by matching their individual propensity for receiving therapy with tocilizumab, conditional on their demographic and clinical variables.Results:A total of 544 COVID-19 patients were included, 197 (36.2%) were treated with tocilizumab of whom 147 were treated within the first 72h after admission; and 347 were included in the control group. After PSM analyses, the results showed no association between tocilizumab use and overall mortality (OR=1.03, 95%CI: 0.63–1.68). However, shorter ICU-stay in the tocilizumab group was found compared to the control group (Coefficient −4.27 95%CI: −6.63 to −1.92). Similar results were found in the early tocilizumab cohort.Conclusions:The administration of tocilizumab in patients with moderate to severe COVID-19 did not reduce the risk of mortality in our cohort of patients, regardless of the time of administration. (AU)

Introducción y objetivos:El tocilizumab es un agente bloqueador del receptor de la interleucina 6 propuesto para el tratamiento de la COVID-19 grave; sin embargo, se dispone de datos limitados sobre su eficacia. El objetivo de este estudio fue evaluar el efecto de tocilizumab en los resultados de los pacientes con neumonía por COVID-19 mediante un análisis de emparejamiento por propensity-score-matching (PSM, «puntuación de propensión»).Métodos:Se realizó un análisis observacional retrospectivo de los pacientes adultos con COVID-19 ingresados en el Hospital Vall d’Hebron entre marzo y abril de 2020. Se utilizó la regresión logística para analizar el efecto de tocilizumab en la mortalidad, como resultado principal, y el análisis PSM para validar aún más su efecto. Los resultados secundarios fueron la duración de la estancia y la estancia en la unidad de cuidados intensivos (UCI). También se evaluaron los mismos resultados para la administración temprana de tocilizumab, dentro de las 72h posteriores al ingreso. Los pacientes se seleccionaron mediante el emparejamiento de su propensión individual a recibir tratamiento con tocilizumab, condicionado a sus variables demográficas y clínicas.Resultados:Se incluyeron 544 pacientes de COVID-19, 197 (36,2%) fueron tratados con tocilizumab, de los cuales 147 fueron tratados dentro de las primeras 72h tras el ingreso; y 347 fueron incluidos en el grupo control. Tras los análisis PSM, los resultados no mostraron ninguna asociación entre el uso de tocilizumab y la mortalidad global (OR=1,03; IC del 95%: 0,63-1,68). Sin embargo, se encontró una menor estancia en la UCI en el grupo de tocilizumab en comparación con el grupo de control (coeficiente −4,27; IC del 95%: −6,63−−1,92). Se encontraron resultados similares en la cohorte de tocilizumab temprano. (AU)

Effect of tocilizumab versus standard of care in adults hospitalized with moderate-severe COVID-19 pneumonia.

INTRODUCTION AND OBJECTIVES: Tocilizumab is an interleukin-6 receptor-blocking agent proposed for the treatment of severe COVID-19; however, limited data are available on their efficacy. The aim of this study was to assess the effect of tocilizumab on the outcomes of patients with COVID-19 pneumonia by using propensity-score-matching (PSM) analysis. METHODS: A retrospective observational analysis of hospitalized COVID-19 adult patients admitted to the Vall d'Hebron Hospital was performed between March and April 2020. We used the logistic regression to analyze the effect of tocilizumab on mortality, as main outcome, and PSM analysis to further validate their effect. Secondary outcomes were length-of-stay (LOS) and intensive-care-unit (ICU) stay. Same outcomes were also assessed for early tocilizumab administration, within 72h after admission. Patients were selected by matching their individual propensity for receiving therapy with tocilizumab, conditional on their demographic and clinical variables. RESULTS: A total of 544 COVID-19 patients were included, 197 (36.2%) were treated with tocilizumab of whom 147 were treated within the first 72h after admission; and 347 were included in the control group. After PSM analyses, the results showed no association between tocilizumab use and overall mortality (OR=1.03, 95%CI: 0.63-1.68). However, shorter ICU-stay in the tocilizumab group was found compared to the control group (Coefficient -4.27 95%CI: -6.63 to -1.92). Similar results were found in the early tocilizumab cohort. CONCLUSIONS: The administration of tocilizumab in patients with moderate to severe COVID-19 did not reduce the risk of mortality in our cohort of patients, regardless of the time of administration.

Parenteral nutrition: a call to action for harmonization of policies to increase patient safety.

Unsafe medication practices and medication errors are leading causes of injury and avoidable harm worldwide and are highest in vulnerable groups. In 2017, the World Health Organization launched the third Medication Without Harm Global Patient Safety Challenge to try to reduce risks related to medical treatment. Parenteral nutrition (PN) is in the unique position that, although licensed products are available from manufacturers, formulas may be prepared ad hoc for first-line use that might not be subject to the same regulatory oversight. Safety issues around PN can arise through lack of harmonization in practices, misinterpretation and product unfamiliarity and can occur at any stage from prescription to preparation to administration. Government legislation and regulation vary considerably, with PN not explicitly handled in many countries. We therefore call on policy leaders in all countries to establish policies that ensure patient safety, and that these include PN along with medicines. The available evidence supports obtaining industry prepared PN as first-line therapy for reasons of safety, primarily, and of cost. If a suitable industry prepared ready-to-use PN is not available, standardized all-in-one PN admixtures should be the next line of care, with individualized PN being reserved for patients whose complex nutritional needs cannot be met using standardized admixtures.

Cohort Multicenter Study on the Role of Medications in Parenteral Nutrition-Related Alteration of Liver Function Tests in Adults.

BACKGROUND: Our objective was to assess in non-critically-ill adult inpatients receiving parenteral nutrition (PN) the risk of developing liver function test (LFT) alterations when receiving concomitant possibly hepatotoxic medications or others reported to improve LFTs during PN. METHODS: A multicenter retrospective analysis of prospectively collected data was performed on patients receiving PN. Two groups were recruited: group LALT (patients with any LFT alterations during PN), and group NOLALT (patients without such alterations). Exclusion criteria were previous sepsis, shock, renal failure, hyperglycemia, LFT alteration, or biliopancreatic surgical procedures. Medications were classified into 2 categories: medications reported to improve LFTs during PN (n = 8) and possibly hepatotoxic medications (n = 54), including a subgroup of possibly highly hepatotoxic medications (n = 30). RESULTS: The study included 200 patients, 136 (68.0%) in the LALT group. The groups differed in the number of patients requiring surgical intervention ≤7 days before PN (LALT, 94 [69.1%]; NOLALT, 29 [45.3%]; P < .002) and those receiving possibly hepatotoxic medications (LALT, 126 [92.6%]; NOLALT, 45 [70.3%]; P < .001). Variables in the final Cox regression model were possibly hepatotoxic medications, odds ratio (OR) 3.310 (1.678-6.530); surgical intervention prior to PN, OR 1.861 (1.277-2.711); baseline triglyceridemia, OR 1.005 (1.001-1.009); and creatinine, OR 1.861 (1.043-3.323). CONCLUSIONS: Patients who received PN and concomitantly possibly hepatotoxic medications had a 3-fold risk of developing LFT alterations. Medications reported to improve LFTs had no effect. The use of possibly hepatotoxic medications during PN was associated with LFT alterations.

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.

Cost, Time, and Error Assessment During Preparation of Parenteral Nutrition: Multichamber Bags Versus Hospital-Compounded Bags.

BACKGROUND: Parenteral nutrition (PN) is associated with material and manpower costs and requires preparation time. The aim of this study was to evaluate the cost of PN using multichamber bags (MCBs) compared with hospital-compounded bags (COBs). The secondary aim of this study was to assess and compare preparation time and errors related to the production and preparation processes of PN bags. MATERIALS AND METHODS: A prospective, observational, cost-accounting study was conducted in 10 Spanish hospital pharmacy services. The cost assessments included components, raw materials, and hospital staff. Only PN bags with equivalent volume and nutrition value were included in the analyses. Assessment of errors related to PN was performed simultaneously with the cost and time comparison analyses. RESULTS: Among the 597 PN bags (295 MCBs, 302 COBs) evaluated, 392 PN bags (295 MCBs, 97 COBs) had an equivalent volume and nutrition value. The mean (standard deviation) total cost of the MCB was $62.11 ($12.34) per bag compared with $67.54 ($8.50) per bag for COBs, resulting in a significant cost savings of $5.71. On average, the time required to prepare an MCB was 38 minutes shorter (P < .001). Significantly fewer total number (percent) of errors was observed in the preparation of MCBs (3 [1.0%]) compared with COBs (15 [5.0%]); P < .01). CONCLUSION: The use of MCBs results in significant savings in cost and preparation time, which may have a beneficial effect on the economic burden associated with PN as well as a reduction in errors related to PN preparation.

Multicenter study of parenteral nutrition in non-critically ill elderly patients compared to younger patients - Study IAIOS-PN (Incidence and Assessment of Iatrogenesis in Older Subjects receiving Parenteral Nutrition).

OBJECTIVE: this study assessed the incidence of hyperglycemia, hypertriglyceridemia, and liver function test (LFT) alterations among patients older and younger than 65 years receiving parenteral nutrition (PN). A secondary objective was to compare the incidence of any of these three events. MATERIAL AND METHODS: inclusion criteria were non-critically ill adult inpatients receiving PN for ≥ 7 days in 15 hospitals in Spain. Exclusion criteria were hyperglycemia, hypertriglyceridemia, LFT alterations, sepsis, shock, pancreatic/hepatobiliary surgery, renal failure, diabetes mellitus (DM) type 1, insulin-treated DM type 2, acute DM complications, or obesity prior to PN. Patients were classified into groups YOUNG (aged 35-64) and OLD (aged 65-95). RESULTS: this study recruited 200 patients. Group YOUNG included 63 (31.5%) patients and OLD, 137 (68.5%). Hyperglycemia appeared in 37 (18.5%) patients, eight (12.7%) in group YOUNG and 29 (21.2%) in group OLD (p = 0.174). Hypertriglyceridemia appeared in only one (0.7%) patient. LFT alterations appeared in 141 (70.5%) patients, 44 (69.8%) in group YOUNG and 97 (70.8%) in group OLD (p = 1.000). The model for hyperglycemia included DM type 2, previous surgical procedure, and use of hyperglycemia-inducing medications. The model for LFT alteration included previous surgical procedure, amount of lipids and amino acids, medications causing LFT alterations and a trend for age group. The model for any event included surgical procedure, DM type 2, and medications causing alterations. CONCLUSION: patients of ≥ 65 years receiving PN had similar incidences of hyperglycemia, hypertriglyceridemia, and LFT alterations as younger patients. Additionally, older patients had trends toward lower LFT alterations.