Association of Standardized Parenteral Nutrition with Early Neonatal Growth of Moderately Preterm Infants: A Population-Based Cohort Study.

In preterm infants, early nutrient intake during the first week of life often depends on parenteral nutrition. This study aimed to evaluate the influence of standardized parenteral nutrition using three-in-one double-chamber solutions (3-in-1 STD-PN) on early neonatal growth in a cohort of moderately preterm (MP) infants. This population-based, observational cohort study included preterm infants admitted to neonatal centers in the southeast regional perinatal network in France. During the study period, 315 MP infants with gestational ages between 320/7 and 346/7 weeks who required parenteral nutrition from birth until day-of-life 3 (DoL3) were included; 178 received 3-in-1 STD-PN solution (56.5%). Multivariate regression was used to assess the factors associated with the relative body-weight difference between days 1 and 7 (RBWD DoL1-7). Infants receiving 3-in-1 STD-PN lost 36% less body weight during the first week of life, with median RBWD DoL1-7 of -2.5% vs. -3.9% in infants receiving other PN solutions (p < 0.05). They also received higher parenteral energy and protein intakes during the overall first week, with 85% (p < 0.0001) and 27% (p < 0.0001) more energy and protein on DoL 3. After adjusting for confounding factors, RBWD DoL1-7 was significantly lower in the 3-in-1 STD-NP group than in their counterparts, with beta (standard deviation) = 2.08 (0.91), p = 0.02. The use of 3-in-1 STD-PN provided better energy and protein intake and limited early weight loss in MP infants.

Electron Microscopy for the Stability Assessment of Parenteral Nutrition Admixtures: Focus on Precipitation.

(1) Background: parenteral nutrition (PN) is indispensable for patients unable to receive oral or enteral feeding. However, the complexity of PN solutions presents challenges regarding stability and compatibility. Precipitation reactions may occur. The most frequent is the formation of calcium phosphate (Ca-P). The different factors influencing these reactions must be considered to ensure patient safety. (2) Methods: eight paediatric PN solutions were prepared, following standard protocols. Samples were stored at room temperature and in a refrigerator. Electron microscopy, coupled with energy dispersive X-ray spectroscopy (EDS), was employed. Precipitates were analysed for composition and morphology. (3) Results: precipitates were observed in all samples, even at day 0. Crystalline structures, predominantly composed of calcium or magnesium, sometimes associated with chlorine or phosphorus, were detected. Additionally, amorphous precipitates, contained heterogeneous compositions, including unexpected elements, were identified. (4) Conclusions: various precipitates, primarily calcium- or magnesium-based, can form in PN solutions, although it is not expected that they can form under the real conditions of use. Calcium oxalate precipitation has been characterised, but the use of organic calcium and phosphate salts appears to mitigate calcium phosphate precipitation. Electron microscopy provides interesting results on NP precipitation, but sample preparation may present technical limitations that affect the interpretation of the results.

Compatibility studies of selected multichamber bag parenteral nutrition with fluconazole.

OBJECTIVE: Fluconazole (FLZ) is a drug widely used in the treatment of fungal infections including the treatment of immunocompromised patients, HIV-infected patients, and cancer patients. Critically ill patients often require the administration of drugs with parenteral nutrition (PN). The safety of this combination should be defined before the drug and PN are administered in one infusion line. This study aimed to determine the compatibility of FLZ with six selected multichamber bag parenteral nutrition. METHODS: FLZ solution for infusion was combined with PNs in appropriate proportions, considering most clinical situations resulting from different possible administration rates of the preparations. Samples were visually assessed, and pH, osmolality, turbidity, particle size (dynamic light scattering and light obscuration methods), and zeta potential were measured. These measurements were made immediately after combining the solutions and after 4 h of storage at 23 ± 1°C. RESULTS: FLZ combined with PNs did not cause changes observed visually. The turbidity of the samples was <0.4 NTU. The average particle size of the lipid emulsion was below 300 nm, and the PFAT5 parameter was ≤0.02%. The absolute value of the zeta potential of the PN + FLZ samples was higher for 5 out of 6 PN than the corresponding value for PN immediately after activation. Changes in pH and osmolality during 4 h of sample observations were within acceptable limits. CONCLUSION: Compatibility of the FLZ with six multichamber bag PN was confirmed. Hence, those preparations can be administered to patients in one infusion line using the Y-site.

Nutritional Support for Moderate-to-Late-Preterm Infants - A Randomized Trial.

BACKGROUND: Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking. METHODS: We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding). RESULTS: A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant. CONCLUSIONS: This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).

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.

Global availability of parenteral nutrition: Pre- and post-COVID-19 pandemic surveys.

OBJECTIVE: Parenteral nutrition represents a therapeutic option for patients with type 3 intestinal failure. If used exclusively, parenteral nutrition has to be complete to provide all essential nutrients. The aim was to assess the availability of parenteral nutrition in all parts of the world, to better comprehend the global situation, and to prepare an action plan to increase access to parenteral nutrition. METHODS: An international survey using an electronic questionnaire was conducted in August 2019 and repeated in May 2022. An electronic questionnaire was sent to 52 members or affiliates of the International Clinical Nutrition Section of the American Society for Parenteral and Enteral Nutrition. Questions addressed the availability of parenteral nutrition admixtures and their components, reimbursement, and prescribing pre- and post-COVID-19 pandemic. All participating countries were categorized by their economic status. RESULTS: Thirty-six country representatives responded, answering all questions. Parenteral nutrition was available in all countries (100%), but in four countries (11.1%) three-chamber bags were the only option, and in six countries a multibottle system was still used. Liver-sparing amino acids were available in 18 (50%), kidney-sparing in eight (22.2%), and electrolyte-free in 11 (30.5%) countries (30.5%). In most countries (n = 28; 79.4%), fat-soluble and water-soluble vitamins were available. Trace elements solutions were unavailable in four (11.1%) countries. Parenteral nutrition was reimbursed in most countries (n = 33; 91.6%). No significant problems due to the coronavirus pandemic were reported. CONCLUSIONS: Despite the apparent high availability of parenteral nutrition worldwide, there are some factors that may have a substantial effect on the quality of parenteral nutrition admixtures. These shortages create an environment of inequality.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control. / [Artículo traducido] Detección y reducción de errores en la elaboración de la nutrición parenteral mediante control gravimétrico y de producto.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutrition between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (p < 0.05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (p < 0.05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutritions between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (P < .05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (P < .05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

False-positive results of galactomannan assays in patients administered glucose-containing solutions.

Galactomannan (GM) is a polysaccharide cell wall component released by Aspergillus spp., and an immunoenzymatic GM assay is used for the diagnosis of invasive pulmonary aspergillosis. We evaluated the cause of strong positivity for GM in patients with no typical signs of aspergillosis. Repeat assays were performed using different instruments and reagent lots, but there were no differences in results among the assays. Patients with strongly positive GM results were investigated. Medication histories revealed that 14 of 23 patients had been administered total parenteral nutrition solution from one manufacturer and 4 patients had been administered dextrose solution from a different manufacturer before being tested. The results of GM assays conducted on samples of dextrose solution and the glucose fraction of the total parenteral nutrition solution were strongly positive, confirming the causes of the false-positive reactions. We hypothesize that a trace amount of GM was introduced into the glucose-containing solutions because glucoamylase, which is necessary for the saccharification step of glucose synthesis, was derived from Aspergillus niger. To enhance patient care and prevent unnecessary antifungal prescriptions, healthcare providers and manufacturers of healthcare products need to be aware of the possibility of false-positive reactions for GM.

Neurodevelopmental Outcome in Very Preterm Infants Randomised to Receive Two Different Standardised, Concentrated Parenteral Nutrition Regimens.

We have previously shown that increasing parenteral protein (target: 3.8 versus 2.8 g/kg/d) and energy (12% versus 10% glucose; 3.8 versus 2.8 g/kg/d) intake using a Standardised, Concentrated with Added Macronutrients Parenteral (SCAMP) nutrition regimen ameliorates early head growth failure in very-preterm infants (VPIs). We hypothesised that the SCAMP nutrition regimen would also improve neurodevelopmental outcome. The original double-blind randomised, controlled study (ISRCTN: 76597892) received ethical approval. VPIs were randomised to either start SCAMP or remain on the control regimen. The consent process included neurodevelopmental assessments (Bayley III), all of which were performed (blinded) at 2-3.5 years of corrected gestational age. Bayley III assessments were performed for 38/60 SCAMP survivors and 41/63 control survivors at means of (sd) 29.2 (3.7) and 20.0 (3.9) months, respectively. Motor, cognitive, language, and combined scores were all higher in the SCAMP intervention group, but none of the differences were statistically significant. Nutrient intake and biochemical monitoring data confirmed that protein/energy ratios were maintained in the SCAMP intervention group without increasing the incidence of hyperglycaemia, insulin treatment, or the derangement of plasma mineral/electrolyte levels. This study did not show a statistically significant improvement in neurodevelopmental outcome when administering higher parenteral protein/energy intakes despite optimal energy and mineral intakes.

Unexpected Serum and Urine Aluminum Concentrations in Pediatric Patients on Home Parenteral Nutrition.

The intravenous supply of aluminum (Al) present in parenteral nutrition solutions poses a high risk of the absorption of this element, which can result in metabolic bone disease, anemia, and neurological complications. The aim of this study is to determine the impact of long-term parenteral nutrition (PN) in children on serum Al concentration and its urinary excretion compared to healthy children. We evaluated serum Al concentrations and its urinary excretion in patients enrolled in the Polish home parenteral nutrition (HPN) program between 2004 and 2022. The study group included 83 patients and the control group consisted of 121 healthy children. In children whose PN was started in the neonatal period, we found higher serum Al concentrations and higher urinary Al excretion than in other subjects whose PN was started later. Only 12% of the children on chronic parenteral nutrition had serum Al concentrations of less than 5 µg/L. Healthy children in the control group had higher serum Al concentrations than those in the parenteral nutrition group, which may indicate the influence of one's environment and diet on Al serum levels.

Stability and compatibility of parenteral nutrition solutions; a review of influencing factors.

Both stability and compatibility of parenteral nutrition solutions (PNS) with drug products are major concerns for clinicians and clinical pharmacists, especially when concurrent administration of PNS with intravenous medications (IVM) is unavoidable. Since the same physicochemical principles apply to both adult's and paediatrics' PNS, concerns about stability and compatibility may still apply to both. However, these concerns are relatively more common in paediatrics and neonatal clinical settings, where limited vascular access can be problematic and the coadministration of PNS and drugs is more common. In neonatal and paediatric populations, there have been few experimental studies and comprehensive evaluations looking at medication compatibility with frequently used PNS. This work is part of a larger research project concerned for compatibility of PNS with commonly used intravenous medication in paediatric and neonates. This paper captures and reviews published data on factors influencing stability and compatibility of parenteral nutrition solutions. This information will help clinicians and clinical pharmacists to understand the principals of the stability and compatibility of PNS, furthermore, it will inform better design of future compatibility studies, as it highlights the complexity of PNS and the multiple factors influencing the stability of PNS, and hence its compatibility with IVM. When preparing, prescribing, and administering the PNS, especially when co-administration with IVM is unavoidable, it is important to take into account the physicochemical properties of the PNS components and IVM as well as administration conditions and environmental factors. These factors should also be considered in the design of the compatibility studies of the PNS with the IVM.

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.

Peripheral Parenteral Nutrition Solutions and Bed Bath Towels as Risk Factors for Nosocomial Peripheral Venous Catheter-related Bloodstream Infection by Bacillus cereus.

In Japan, China, and Singapore, several studies have reported increased incidences of peripheral venous catheter-related bloodstream infection by Bacillus cereus during the summer. Therefore, we hypothesized that bed bathing with a B. cereus-contaminated "clean" towels increases B. cereus contact with the catheter and increases the odds of contaminating the peripheral parenteral nutrition (PPN). We found that 1) professionally laundered "clean" towels used in hospitals have B. cereus (3.3×104 colony forming units (CFUs) / 25cm2), 2) B. cereus is transferable onto the forearms of volunteers by wiping with the towels (n=9), and 3) B. cereus remain detectable (80∼660 CFUs /50cm2) on the forearms of volunteers even with subsequent efforts of disinfection using alcohol wipes. We further confirmed that B. cereus grow robustly (102 CFUs /mL to more than 106 CFUs /mL) within 24hours at 30°C in PPN. Altogether we find that bed bathing with a towel contaminated with B. cereus leads to spore attachments to the skin, and that B. cereus can proliferate at an accelerated rate at 30°C compared to 20°C in PPN. We therefore highly recommend ensuring the use of sterile bed bath towels prior to PPN administration with catheter in patients requiring bed bathing.

Peripheral parenteral nutrition in surgery - a systematic review and meta-analysis.

BACKGROUND: Peripheral parenteral nutrition (PPN) refers to the delivery of artificial nutrition via a peripheral intravenous cannula. As a nutritional intervention it remains under-utilised in peri-operative care. This is despite purported advantages which includes avoiding the risks associated with central venous lines and preventing potential delays to the initiation of nutrition support. This systematic review and meta-analysis will detail the available evidence for PPN use in surgery. METHODS: A comprehensive search of the EMBASE and Medline databases was undertaken to identify randomised control trials (RCTs) involving PPN use in surgical patients published until July 30th 2022. Three domains of PPN use were reviewed including: PPN compared to crystalloid intravenous fluids on nutritional and clinical outcomes; PPN compared to Central PN (CPN) on nutritional outcomes and complications; and strategies to prevent thrombophlebitis associated with PPN. RESULTS: The meta-analysis included 8 studies which included 698 patients. Use of PPN led to reduced post-operative weight loss (% body weight change) with a mean difference of -1.45% (95% CI -2.9 to -0.01, p = 0.05). There was no statistically significant difference in terms of length of stay, infectious/non-infectious complications, surgical site infections or phlebitis. 42 RCTs were included in the systematic review. 14 RCTs compared PPN to crystalloid infusion. There was significant heterogeneity in the trial populations, interventions and measured outcomes. Most trials found that PPN may improve nitrogen balance and positively impact nutritional markers. Quality of life and post-operative complications were either improved or no difference found in trials assessing these outcomes. Four RCTs showed that PPN is a safe and feasible alternative to CPN. 22 RCTs reported on measures that may impact on thrombophlebitis rates associated with PPN. These included lower osmolality of PPN solution, cyclical PPN delivery, use of a small gauge polyurethane cannula in an upper limb vein, addition of heparin/hydrocortisone to PPN solutions and placement of a GTN patch over infusion sites. CONCLUSION: PPN is a safe and effective mode of delivery of peri-operative nutrition. It is a feasible short-term alternative to central-line delivered PN. There are a number of strategies to reduce thrombophlebitis associated with PPN use. Further high-quality RCTs are required to assess the use of PPN in contemporary surgical practice.

[Review of parenteral nutrition practices in four university hospital's pharmacies in Auvergne-Rhône-Alpes region]. / État des lieux des pratiques de nutrition parentérale dans quatre pharmacies à usage intérieur de centre hospitalier et universitaire de la région Auvergne-Rhône-Alpes.

OBJECTIVES: To carry out an assessment of parenteral nutrition (PN) practices in hospital pharmacies of the Auvergne-Rhône-Alpes region in order to explore a harmonisation of practices and a collaboration between the different centres. METHODS: Status of practices was carried out on the basis of an observational study inspired by the survey of the General Inspectorate of Social Affairs. It was carried out in Auvergne-Rhône-Alpes region in four university hospital pharmacies with a production unit of PN. It focused on the different stages of the PN process: prescription, formulation, compounding and quality control. It also covered the support processes such as the quality assurance system and the management of premises and equipment. RESULTS: Most preparations made in the region are individualized parenteral nutritional admixtures for paediatric and neonatal hospitalization departments. The production units of PN of each centre are located in premises in compliance with Good Preparation Practices. However, compounding equipment and raw materials used are heterogeneous in the four centres. All centres control the quality of their finished preparations. But, the performance of analytical control is disparate in terms of equipment and specifications. CONCLUSION: This assessment explains the similarities and differences in PN practices between various university hospitals in the Auvergne-Rhône-Alpes region and thus makes possible to provide a collective regional work to harmonise practices.

One-chamber and two-chamber parenteral nutrition admixtures for pediatric and adult patients: An evaluation of physico-chemical stability at room and cold temperature.

OBJECTIVES: The aim of this study was to evaluate the physico-chemical stability of compounded total parenteral nutrition admixtures through peroxidation assay and ultraviolet-visible spectroscopy, high-performance liquid chromatography analysis, nuclear magnetic resonance spectrometry, pH meter, and dynamic light scattering. METHODS: The present study considered parenteral nutrition (PN) admixtures for pediatric and adult patients. The admixtures were characterized by a high content of vitamins and trace elements. They were prepared in one- or two-chamber bags in the hospital pharmacy using an automatic compounding system in a sterile room with laminar airflow at different temperature conditions and light exposure. The experiment setup comprised fat emulsions, lipid-free PN solutions, and single-chamber bags before and after adding vitamins and trace elements. The stability at room temperature (+25°C) and cold temperature (+2-8°C) was assessed by various means. RESULTS: Two-compartment admixtures, single-chamber bags, and all-in-one PN supplemented with vitamins and trace elements are stable up until 35, 9, and 7 d, respectively, when protected from light and stored at +2 to 8°C. Also, the supplemented single-chamber PN was found to be stable up to 48 h when stored at +25°C with light exposure. CONCLUSIONS: The results obtained will help improve PN management at the compounding center and in hospital wards, because they allow for the extension of the validity time frame provided so far by the different formulations and, therefore, therapy scheduling over several days.

Existence of advanced glycation / lipoxidation end-products in parenteral nutrition solutions and effects of infusion conditions on their levels

Abstract Infusion solutions must be stable from the production stage until the infusion stage. Some infusion fluids contain degradation products, known as advanced glycation end products (AGEs); however, it is unknown whether AGEs exist in parenteral nutrition solutions. We aimed to investigate this question and test the effect of infusion conditions on AGE formation in parenteral nutrition solution. Nine parenteral nutrition solutions were supplied by the pharmacy with which we collaborated. To simulate the infusion conditions, the solutions were held in a patient room with standard lighting and temperature for 24 hours. Samples were taken at the beginning (group A) and the end (24th hour, group B) of the infusion period. The degradation products were 3-deoxyglucosone, pentosidine, N-carboxymethyl lysine, and 4-hydroxynonenal, which we investigated by high-performance liquid chromatography-mass spectrometry (LC-MS) and Q-TOF LC/MS methods. Two of four degradation products, 4-hydroxynonenal and N-carboxymethyl lysine, were detected in all samples, and Group B had higher levels of both compounds compared to Group A, who showed that the quantities of these compounds increased in room conditions over time. The increase was significant for 4-hydroxynonenal (p=0.03), but not for N-carboxymethyl lysine (p=0.23). Moreover, we detected in the parenteral nutrition solutions a compound that could have been 4-hydroxy-2-butynal or furanone

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.