[Comparative study of production and control processes of parenteral nutritional admixtures in neonatology]. / Étude comparative des processus de production et de contrôle analytique des préparations magistrales de mélanges nutritifs parentéraux en néonatalogie.

OBJECTIVES: To assess the impact of disparities in production and analytical control processes on the quality of parenteral nutrition (PN) preparations produced in the Auvergne-Rhône-Alpes region. METHODS: This study was carried out in four hospital pharmacies of the Auvergne-Rhône-Alpes region. To assess the impact of production processes, each centre produced ten PN preparations from the same prescription. Analytical controls (sodium, potassium and calcium dosage) were carried out on all the preparations. To assess the impact of the control processes, a batch of ten preparations was produced from the same prescription. Samples were sent to the four hospital pharmacies for analytical control (sodium, potassium and calcium dosage). RESULTS: Measurements of relative production bias show that there is a significant difference between the preparations from the four centres in terms of sodium and potassium content. Each centre had at least one production bias for one of the three electrolytes measured. Concerning analytical controls, there was a significant difference between the four centres in the sodium and potassium levels measured. With the exception of calcium, all the centres reported measurements within the usual specifications of±10% of the target value. The results obtained have no clinically significant impact. CONCLUSION: The diversity of NP practices has a real impact on the quality of the preparations made. A regional collaboration should be envisaged to standardise patient care.

[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.

Impact of computerized physician order entry system on parenteral nutrition medication errors in a teaching neonatal intensive care unit.

OBJECTIVES: Parenteral nutrition (PN) offers a quality therapeutic option when enteral feeding is non-tolerated or impossible. However, it can be associated with an increased risk of medical errors, especially in sensitive populations such as newborns. This study aimed at determining the impact of the implementation of a computerized physician order entry (CPOE) system on PN medication errors in the neonatology department in the largest teaching hospital in Tunisia. MATERIEL AND METHODS: The frequency of medication errors in PN, in a teaching neonatal intensive care unit, was prospectively reviewed by a pharmacist between December 2018 and March 2019 in a two-phase interventional study (pre and post locally developed CPOE System implementation). RESULTS: Implementation of CPOE system decreased PN order errors from 379 to 147 representing a 61.1% reduction. The decreases on PN order errors per stage, i.e. prescribing and preparation, were form 207 to 22 (89.4%), and from 117 to 66 (43.6%), respectively. Mean nutrients intakes were in conformity to the recommended daily intakes during the CPOE phase of the study. CPOE is a protective tool against prescription and preparation errors. It significantly impacted all items of the ordering process. CONCLUSIONS: In addition to the rigorous application of the recommendations, the CPOE system allows to reduce the risk of PN medication errors. This improves the safety and quality of medicines in newborns.

[Quality control of mixtures for pediatric parenteral nutrition: Validation of sodium and potassium assay method]. / Contrôle qualité des mélanges pour nutrition parentérale pédiatriques : validation de la méthode de dosage du sodium et du potassium.

OBJECTIVES: Control of electrolyte concentration in mixtures for parenteral nutrition (MPN) for newborns is crucial before the release of the final product. We aimed to assess the validation of the electrolytes assay in MPN. METHODS: Electrolytes assay was performed with Ilyte Analyzer®. Validation of method was realized in accordance with ICH (International Conference on Harmonization) guideline Q2(R1) and the commission report of the French society of pharmaceutical science and technology. Linearity test solutions were prepared in triplicate using five levels of concentrations for sodium and potassium (60-140% of theoretical concentrations). Accuracy of the method was deducted from the same results of linearity. The intermediate precision was ensured by dosing the main electrolyte in six MPN, during three successive days. RESULTS: Linearity was assessed with correlation coefficients greater than 0.996 for both electrolytes. A non-significant result of comparison test of the intercept with zero (Student test) was obtained. A highly significant result of the test of existence of slopes (Fisher test) proved a linear regression for the 2 electrolytes (P<0.1%). Inter-day precision values were 2.68% and 2.65% respectively for sodium and potassium. CONCLUSION: The validation of sodium and potassium assay method was successfully performed with Ilyte Analyzer® allowing routine quality control in MPN.

[Physicochemical stability of individualized parenteral nutrition in neonatal period]. / Stabilité physico-chimique des nutritions parentérales individualisées en néonatologie.

Individualized parenteral nutrition is frequently used in neonatal period because of specific nutritional needs of preterm neonates which are not always covered by industrially produced parenteral nutrition. This review summarizes the risks of physicochemical instability associated with parenteral nutrition preparation in order to make recommendations to secure this mode of preparation.

[Malnutrition in the elderly, screening and treatment]. / Malnutrition chez la personne âgée, dépister et prendre en charge.

Undernutrition is defined as an imbalance between the body's energy intake and requirements. It is present in 30 to 70% of hospitalised elderly people and its consequences are severe. Systematic screening and early treatment are an integral part of global geriatric care. The aetiological approach must be exhaustive (medico-psychosocial problems) and integrate difficulties related to the physiological ageing of the organism.

[Staff accreditation in parenteral nutrition production in hospital pharmacy]. / Mise en place d'une démarche d'habilitation du personnel en pharmacie hospitalière : application à la production de poches de nutrition parentérale.

OBJECTIVES: This work aims to provide staff accreditation methodology to harmonize and secure practices for parenteral nutrition bags preparation. METHODS: The methodology used in the present study is inspired from project management and quality approach. Existing training supports were used to produce accreditation procedure and evaluation supports. RESULTS AND DISCUSSION: We first defined abilities levels, from level 1, corresponding to accredited learning agent to level 3, corresponding to expert accredited agent. Elements assessed for accreditation are: clothing assessment either by practices audit or by microbiologic test, test bags preparation and handling assessment, bag production to assess aseptic filling for both manual or automatized method, practices audit, number of days of production, and non-conformity following. At Angers Hospital, in 2014, production staff is composed of 12 agents. Staff accreditation reveals that 2 agents achieve level 3, 8 agents achieve level 2 and 2 agents are level 1. We noted that non-conformity decreased as accreditation took place from 81 in 2009 to 0 in 2014. CONCLUSION: To date, there is no incident due to parenteral bag produced by Angers hospital for neonatal resuscitation children. Such a consistent study is essential to insure a secured nutrition parenteral production. This also provides a satisfying quality care for patients.

[Advantages and special features of hospital preparations of parenteral nutrition in neonatalogy]. / Avantages et spécificités des préparations hospitalières de nutrition parentérale en néonatalogie.

INTRODUCTION: The care of premature infants requires specific, suitable parenteral nutrition, in which the dosage must be frequently adjusted. METHOD: A comparative analysis of four industrial standard parenteral nutrition formulations NP 100®, Pediaven AP-HP Nouveau-né 1®, Pediaven AP-HP Nouveau-né 2® and Numetah G13% E® and of two hospital preparations made specifically in hospital pharmacies produced by two separate university hospitals (Nutrine® HCL and Formule standardisée début de nutrition) was conducted. The comparison between the formulations focused on electrolytic compositions and protein/energy ratio. RESULTS: Formule standardisée début de nutrition and Pediaven AP-HP Nouveau-né 1® are free from (i) sodium and potassium, (ii) potassium respectively. Almost equivalent sodium concentration (19-27 mM) and more variable potassium concentration (∼9-26 mM) characterize the other formulations. Protein/energy ratio of Numetah G13% E®, Nutrine® HCL and Formule standardisée début de nutrition is 58% higher than that of NP 100®, Pediaven AP-HP Nouveau-né 1® and Pediaven AP-HP Nouveau-né 2®. DISCUSSION: Formule standardisée début de nutrition and Pediaven AP-HP Nouveau-né 1® are in accordance with the recommendations about hydro-electrolytic supplies during transition phase. Nutrine® HCL complies best to the recommendations about hydro-electrolytic account during stabilization phase. CONCLUSION: Hydro-electrolytic composition and protein/energy ratio of standard hospital parenteral nutrition formulations comply best to nutritional needs of premature infants.

Assessment of anti-factor Xa activity of heparin in binary parenteral nutrition admixtures for premature neonates.

An in vitro study was carried out to determine the anti-Xa activity of heparin in binary parenteral nutrition (BPN) admixtures for premature neonates in our neonatal intensive care unit (NICU) after a 24-hour infusion, as well as to assess drug interaction with a 50% glucose solution. Two types of bags were prepared: (1) BPN admixtures (composition defined in the NICU) including sodium heparin at 77 UI/mL and (2) bags containing only G50% with sodium heparin at 193 UI/mL. The anti-Xa activity of heparin was measured in bags at T0, after the 24-hour infusion and in eluates at the outlet of the infusion line after 24hours, using a validated chromogenic anti-Xa method. Comparisons of the mean concentration observed with the theoretical value for anti-Xa activity were performed with the Student t-test. Mean values of anti-Xa activity do not differ significantly from the values expected for all conditions. We found a slight variation in anti-Xa activity when infused over 24hours for both types of bags, with and without in-line filtration, showing that heparin remains stable during this infusion period in both BPN admixtures and G50%.

[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing]. / Étude de l'impact physicochimique et bactériologique d'un montage hebdomadaire de l'automate BAXA(®) Exacta-Mix 2400 sur la fabrication des poches de nutrition parentérale.

INTRODUCTION: The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested. MATERIALS AND METHODS: Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring. RESULTS: All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found. DISCUSSION AND CONCLUSIONS: The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

[Nutritional management of patients during surgical prehabilitation and rehabilitation programs]. / Prise en charge nutritionnelle des patients pendant les programmes de préhabilitation et de réhabilitation en chirurgie.

Undernutrition (UD) increases perioperative morbidity and mortality. Its prevention and treatment are therefore essential in surgical prehabilitation and rehabilitation programs. Nutritional treatment is individualized according to the patient's nutritional status, ingesta and protein-energy requirements. Oral nutrition is optimized to increase intakes through personalized dietary advice and oral nutritional supplements. Artificial nutrition support is indicated in cases of UD or high risk of UD before major surgery. Enteral nutrition is preferred to parenteral nutrition when the digestive tract is functional.

[Severe small bowel involvement and chronic intestinal pseudo-obstruction in systemic sclerosis (scleroderma): Pathophysiological, diagnostic and therapeutic basis, including parenteral nutrition]. / Atteinte sévère de l'intestin grêle et pseudo-obstruction intestinale chronique au cours de la sclérodermie systémique : bases physiopathologiques, diagnostiques et thérapeutiques, dont la nutrition parentérale.

Gastrointestinal involvement in systemic sclerosis can be severe, reaching the critical point of chronic intestinal pseudo-obstruction, secondary to major disorders of small bowel motility. It is associated with some clinical and biological characteristics, in particular the positivity of anti-fibrillarin/U3RNP antibodies. Chronic intestinal pseudo-obstruction (CIPO) is complicated by a small intestinal bacterial overgrowth that requires cyclic antibiotic therapy. CIPO leads to a reduction of the food intake, due to painful symptoms, nausea and vomiting caused by meals, and ultimately to severe malnutrition. Meal splitting is often transiently effective and patients require exogenous nutritional support, mostly parenteral. Systemic sclerosis is not an obstacle to initiation and long-term continuation of parenteral nutrition and central venous catheter implantation is not associated with an increased risk of cutaneous or infectious complications. However, continuation of long-term parenteral nutrition requires monitoring in an expert nutrition center in order to adapt nutritional volumes and intakes and to limit potentially fatal cardiac and hepatobiliary complications. In addition to nutrition, prokinetic treatments, whose side effects must be known, can be associated. Invasive procedures, whose risk-benefit ratio must be carefully assessed, can also be used to treat symptoms exclusively.

[Stability and sterility of parenteral nutrition admixture for patients home care manufactured by the automated compounding BAXA® EM 2400]. / Étude de stabilité et de stérilité des poches de nutrition parentérale pour patients à domicile fabriquées à l'aide de l'automate BAXA® EM 2400.

INTRODUCTION: Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used. MATERIALS AND METHODS: Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14). To complete these checks, the emulsions were analyzed (size, stability, optical microscopy) at D0 and D14. Finally, microbiological research (Bact-Alert(®), filtration membrane sterility tests Steritest(®) and plate count agar) was performed. RESULTS: No lipid cluster was observed with an optical microscope. Comparison of data observed for all controls showed no significant difference in the production of D0 by the Wilcoxon test. Microbiology (Bact-Alert filtration membrane sterility tests Steritest(®) and plate count agar) was negative for all samples. Consequently, all mixtures were considered stable. DISCUSSION AND CONCLUSIONS: The automated compounding BAXA(®) EM 2400 ensures quality and safety of production. The results of this study have shown stability and sterility of parenteral nutrition admixtures for 14 days.

[Place of biomarkers in the renutrition of patients with serious Covid-19 infection: discussion around a clinical case]. / Place des biomarqueurs dans la renutrition des patients ayant une infection grave à Covid-19 : discussion autour d'un cas clinique.

Covid-19 infection is a potentially serious disease. Overweight, obesity, and diabetes are comorbidities frequently found in the severe form of the disease. Appropriate nutritional management of the patient is an integral part of care. We will discuss the renutrition of a 76-year-old, obese (BMI = 35kg/m2), malnourished patient, according to the 2021 Haute Autorité de santé criteria, with Covid-19 infection, admitted to the intensive care unit at the Bordeaux University Hospital for an acute respiratory distress syndrome. Adaptation of nutritional intakes was achieved by clinical and biological monitoring. A refeeding syndrome was treated on the first day of hospitalization in the intensive care unit. After thiamine supplementation and when kalemia and phosphatemia have been normalized, renutrition was started. Parenteral nutrition as a complement to oral nutrition was used. Parenteral nutrition was well tolerated; recommended caloric and protein intakes were achieved by the fourth day of hospitalization. The clinical evolution was favorable. In conclusion, patients with Covid-19 infection should be considered malnourished when admitted to the intensive care unit. Macro and micronutrient intakes adapted to metabolically stressed patients are essential. Biological monitoring including monitoring of ionogram, phosphate, uremia, creatinine, liver function tests and blood glucose is essential in the nutritional management of patients with serious Covid-19 infection.

[The management of an adverse event in a paediatric unit]. / La gestion d'un événement indésirable en service de pédiatrie.

Adverse events remain a major issue in care services. The mission of hospital authorities is to analyse them in order to put in place corrective and preventive measures. The objective is to prevent them reoccurring and to ensure the sustainable improvement of the quality and safety of care. This article presents an example in paediatrics with parenteral nutrition.

[Wasting in chronic kidney disease: Refeeding techniques and artificial nutrition practices]. / Dénutrition au cours des maladies rénales chroniques : techniques de renutrition et pratique de la nutrition artificielle.

Protein energy wasting (PEW) is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method used patients. Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.

Protein requirement in critical illness.

How much protein do critically ill patients require? For the many decades that nutritional support has been used there was a broad consensus that critically ill patients need much more protein than required for normal health. Now, however, some clinical investigators recommend limiting all macronutrient provision during the early phase of critical illness. How did these conflicting recommendations emerge? Which of them is correct? This review explains the longstanding recommendation for generous protein provision in critical illness, analyzes the clinical trials now being claimed to refute it, and concludes with suggestions for clinical investigation and practice.

A life-threatening complication of parenteral nutrition: how to prevent cardiac tamponade?

Complications caused by incorrect central venous insertion are numerous. Cardiac tamponade is a rare, but well-documented complication that is often lethal. We present the case of a patient with cardiac tamponade caused by incorrect tip position and infusion of hyperosmolar fluids such as for parenteral nutrition.

Short bowel syndrome in infants: the critical role of luminal nutrients in a management program.

Short bowel syndrome develops when the remnant mass of functioning enterocytes following massive resections cannot support growth or maintain fluid-electrolyte balance and requires parenteral nutrition. Resection itself stimulates the intestine's inherent ability to adapt morphologically and functionally. The capacity to change is very much related to the high turnover rate of enterocytes and is mediated by several signals; these signals are mediated in large part by enteral nutrition. Early initiation of enteral feeding, close clinical monitoring, and ongoing assessment of intestinal adaptation are key to the prevention of irreversible intestinal failure. The length of the functional small bowel remnant is the most important variable affecting outcome. The major objective of intestinal rehabilitation programs is to achieve early oral nutritional autonomy while maintaining normal growth and nutrition status and minimizing total parenteral nutrition related comorbidities such as chronic progressive liver disease. Remarkable progress has been made in terms of survivability and quality of life, especially in the context of coordinated multidisciplinary programs, but much work remains to be done.