Parenteral Nutrition Mixtures Research Articles

Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

AbstractBackgroundPreparation of parenteral nutrition (PN) mixtures is performed in a controlled atmosphere area (CAA) under a laminar flow hood. In 2014 and 2015 quality controls have revealed contaminations of PN bags by Bacillus. The different products used to avoid this contamination were Aniosurf premiumMethodsFive protocols have been tested by varying the disinfection step: hydrogen peroxide (H2O2) or sodium hypochlorite (immersion or spray), ethanol (non sporicidal) only by immersion. Prewash and aerosolization steps remained unchanged. For each series, a quantity of 30 vials have been prewashed, then disinfected according to the tested protocol, and finally aerosolized. In order to quantify the effectiveness of disinfection 10 vials were sampled using contact plates at every step of treatment.ResultsMicroorganisms were found after ethanol disinfection (n=4) and aerosolization (n=2). No germs were found when hydrogen peroxide or sodium hypochlorite were used. The atmospheric rates of H2O2 were 0.2 ppm by immersion and 0.8 ppm by spray, these values are below the recommended value level (1 ppm).ConclusionsThis study has validated the use and effectiveness of these disinfecting products. Taking into account the efficiency and ease of use for staff, immersion has been preferred to spray and hydrogen peroxide to sodium hypochlorite.

SUN-P014: Iron Contamination in Pediatric and Adult Parenteral Nutrition Mixtures

SUN-P014: Iron Contamination in Pediatric and Adult Parenteral Nutrition Mixtures

MON-P190: Quality Control of Mixtures for Pediatric Parenteral Nutrition: Validation of Sodium and Potassium Assay Method

MON-P190: Quality Control of Mixtures for Pediatric Parenteral Nutrition: Validation of Sodium and Potassium Assay Method

Amino acid composition of standard and personalized complete parenteral nutrition mixtures

Amino acid composition of standard and personalized complete parenteral nutrition mixtures

MON-PP009: Frequency and Characteristics of Pump Alarms in Patients on Home Parenteral Nutrition

Rationale: Muscle wasting occurs in elderly, long term muscle disuse, malnutrition and a number of other catabolic conditions. Studies showed that the amino acid composition of whey protein is effective in promoting protein synthesis in skeletal muscle, improving accretion and/or slowing down muscle mass loss in patients with wasting syndrome. This study compares amino acid composition of standard and personalized parenteral nutrition mixtures with that of whey protein. Methods: As many as 113 patients (54 men, 59 women, aged 20 89 years) on home parenteral nutrition were retrospectively recruited. Ten types of standard parenteral nutrition mixtures (SPNMs), industrially manufactured, were prescribed in 75 (66%) patients while compounded personalized parenteral nutrition mixtures (PPNMs) in 38 (34%). The amino acid solution in compounding of personalized parenteral nutrition mixtures was Sintamin 10% (Fresenius Kabi). Results: Setting leucine (Leu) and essential amino acids (EAAs) amounts in whey protein at 100% and the usually daily dose of amino acids (AAs) at 1 g/kg body weight (BW), the mean Leu content adjusted for BW was 86% in PPNMs and 57% in SPNMs, while the BW adjusted EAAs content was 111% and 100%, respectively. Conclusion: Synthesis of muscle proteins needs adequate amount of EAAs, particularly of Leu that regulates protein synthesis in skeletal muscle. Although our data are lacking in comparative effectiveness, they suggest that PPNMs, rather than SPNMs, could have a better AAs composition for patients with muscle wasting because this composition tends to be closer to that of whey protein. In conclusion, mixtures for parenteral nutrition with amino acid composition close to that of whey protein could be recommended to be tested in the clinical practice.

MON-PP008: Amino Acid Composition in Standard and Personalized Parenteral Nutrition Mixtures Compared to Whey Protein

MON-PP008: Amino Acid Composition in Standard and Personalized Parenteral Nutrition Mixtures Compared to Whey Protein

Enquête nationale sur la préparation des mélanges de nutrition parentérale en néonatologie dans les centres hospitaliers tunisiens

Preparation of parenteral nutrition mixtures (PNM) is a high-risk activity which must be under pharmaceutical control. Nowadays, in Tunisia, most hospitals accomplish the preparation of MNP in units of care. The purpose of this survey was to assess preparation and control practices of PNM in Tunisia. This prospective survey was accomplished through direct observation. A grid including 50 questions related to the preparation and the control of the PNM was written. The survey was led in 8 hospitals out of 10. In all the hospitals, the activity of preparation of the PNM is carried in the unit of care. Only 25 % of the cases are accomplished under pharmaceutical control. The annual average production of services is 1735 PNM. Twenty-five percent used only individual PNM and 25 % used only standard PNM. A quarter of teaching hospitals accomplish preparation in a controlled atmosphere zone under laminar air flow hood and 37 % at the patient. Only 12.5 % of teaching hospitals use a system of insurance quality. Fifty percent of teaching hospitals accomplish a control of PNM (visual control of PNM). The test of sterility is only performed in 25 % of cases. This corresponds to the hospitals where preparation is under pharmaceutical responsibility. Different anomalies were put in evidence and concern essentially the absence of a pharmacist in the preparation of PNM and also a failure of PNM control. It is therefore necessary to set up corrective measures.

Parenteral nutrition-associated liver injury and increased GRP94 expression prevented by ω-3 fish oil-based lipid emulsion supplementation.

ABSTRACTObjective:Parenteral nutrition in infants with gastrointestinal disorders can be lifesaving, but it is also associated with parenteral nutrition–associated liver disease. We investigated the effects of incorporating ω-3 fish oil in a parenteral nutrition mixture on signs of parenteral nutrition–associated liver disease and explored the mechanism involved in this process.Methods:Seven-day-old New Zealand rabbits were divided into 3 groups of 8, and for 1 week they were infused via the right jugular vein with standard total parenteral nutrition with soybean oil (TPN-soy) or TPN with ω-3 fish oil–based lipid emulsion (TPN-FO), or naturally nursed with rabbit milk (control). Serum and liver tissues were analyzed for serological indicators and pathology, respectively. Reverse-transcriptase polymerase chain reaction was used to evaluate the messenger RNA levels of the endoplasmic reticulum stress chaperone protein glucose-regulated protein 94 (GRP94) in liver tissues and GRP94 protein levels were compared through immunohistochemistry and Western blot assays.Results:TPN-soy animals had significantly higher serum total bilirubin, direct bilirubin, and γ-glutamyl transpeptidase and lower serum albumin than the controls (P < 0.01, each) or the TPN-FO group, which were similar to the controls (P < 0.01 cf. TPN). Damage to liver tissues of the TPN-FO group was much less than that of the TPN-soy group. GRP94 messenger RNA and protein levels in liver tissues of TPN-soy animals were significantly higher than that of the controls or TPN-FO rabbits, which were similar to the controls.Conclusions:Incorporating ω-3 fish oil in parenteral nutrition emulsion greatly prevented liver dysfunction and liver tissue damage in week-old rabbit kits, possibly by preventing endoplasmic reticulum stress.

PP226-MON: Assessment of the Accuracy and Precision in the Compounding of Parenteral Nutrition Mixtures Manufactured by an Automated Filling System

PP226-MON: Assessment of the Accuracy and Precision in the Compounding of Parenteral Nutrition Mixtures Manufactured by an Automated Filling System

PP277-MON: Outstanding abstract: Molybdenum Content in Individual Components Used to Prepare Total Parenteral Nutrition Mixtures: Preliminary Study

PP277-MON: Outstanding abstract: Molybdenum Content in Individual Components Used to Prepare Total Parenteral Nutrition Mixtures: Preliminary Study

Use of the Six Sigma methodology for the preparation of parenteral nutrition mixtures

To use the tools of the Six Sigma methodology for the statistical control in the elaboration of parenteral nutrition mixtures at the critical checkpoint of specific density. Between August of 2010 and September of 2013, specific density analysis was performed to 100% of the samples, and the data were divided in two groups, adults and neonates. The percentage of acceptance, the trend graphs, and the sigma level were determined. A normality analysis was carried out by using the Shapiro Wilk test and the total percentage of mixtures within the specification limits was calculated. The specific density data between August of 2010 and September of 2013 comply with the normality test (W = 0.94) and show improvement in sigma level through time, reaching 6/6 in adults and 3.8/6 in neonates. 100% of the mixtures comply with the specification limits for adults and neonates, always within the control limits during the process. The improvement plans together with the Six Sigma methodology allow controlling the process, and warrant the agreement between the medical prescription and the content of the mixture.

PS-035 The use of a different amino acid solution in total parenteral nutrition mixtures for critical newborns

BackgroundAt the request of the intensive neonatal care unit, in order to give the babies less fluid, we replaced the usual amino acid mixture TPH 6% with Primene 10%. After...

Composition of personalized and standard nutritional mixtures in patients on home parenteral nutrition

The compounding of personalized parenteral nutrition mixtures (PPNMs) for home parenteral nutrition (HPN) gives the possibility to better satisfy nutritional requirements for patients in selected clinical conditions. The objective of this study was to compare the composition of PPNMs prescribed in selected cases, by a practitioner nutritionist, with that of industrially manufactured standard parenteral nutrition mixtures (SPNMs). Two hundred and ninety-eight patients (151 men, 147 women, aged 17-87 years) on HPN, followed up in 2011 at our Center, were retrospectively recruited. Industrially manufactured SPNMs were prescribed in 230 (77.2%) patients, whereas compounded PPNMs were prescribed in 68 (22.8%). Formulation of PPNMs, adjusted for body weight, did not significantly differ from SPNMs as regards total daily calorie amount, but was significantly different as far as nutrient composition is concerned (P<0.01). Analysis on the daily amount of nutrients per kg of body weight and per patient disease showed that 16/34 (47%) benign chronic intestinal failure (CIF) patients, 47/233 (20%) cancer patients and 5/31 (16%) patients grouped as 'having other diseases' needed personalized mixtures (in PPNMs 4-9 nutrients were significantly different from those in SPNMs). Moreover, in CIF patients receiving PPNMs, frequent changes in the formulation (mean 6 times per year, range 1-28) were necessary. Our data suggest that, presently, PPNMs cannot be completely replaced by SPNMs owing to special needs in macro and/or micronutrients of some patients and/or the necessity of frequent changes in the nutritional mixture composition, at least until stabilization of clinical and metabolic conditions.

Relationship between copper doses in parenteral nutrition mixtures, serum copper, erythrocyte copper levels, ceruloplasmin and C-reactive protein, in critically ill patients

Summary Background and aims There is no consensus on the recommended amounts of copper to be administered to critically ill patients on parenteral nutrition, as requirements are variable and very difficult to determine in different disease states. The objective of this study was to assess copper status of critically ill patients on total parenteral nutrition in order to prevent inadequate copper administration. Methods The study comprised adult patients (20 males and 10 females) requiring total parenteral nutrition for 4–21 days, because of pancreatitis ( n = 5) or after major abdominal surgery ( n = 25). Parenteral nutrition was discontinued when the patient tolerated enteral or oral feeding. The following parameters were determined throughout the study (4–21 days): total copper administered by parenteral nutrition, serum copper, erythrocyte copper (Atomic Absorption Spectrometry); serum ceruloplasmin (Ferroxidase activity) and C-reactive protein levels (Immunoturbidimetry, Latex HS). Results Total copper administered in parenteral nutrition ranged between 0.03 and 3.8 mg/d, and was higher than prescribed amounts due to copper contamination of individual components. The amount of copper given in parenteral nutrition correlated with changes in erythrocyte copper, but not with changes in serum copper, ceruloplasmin, or C-reactive protein. Conclusions Variations in erythrocyte copper levels showed significant correlation with the amount of copper administered daily in parenteral nutrition mixtures, and this biochemical indicator could be useful to monitor copper deficiency or excess in patients on parenteral nutrition. It is noteworthy that copper delivery above 1.2 mg/d was frequent and prompts such monitoring.

Contenants et contaminants en nutrition parentérale : l’aluminium, un revenant ?

Aluminium is a well-known potentially hazardous contaminant in parenteral preparation for dialysis or drug delivery. The main objective of the study is to assess aluminium exposure from chronic parenteral nutrition supply. The specific objectives of the study were (i) to assess aluminium concentration in parenteral nutrition compounds (n=26) and in hospital-made parenteral nutrition mixture (n=56), (ii) to compare aluminium concentration in nutrition products to the maximum allowable concentration (i.e. 25μg/L), and finally (iii) to compare the daily rate infused per kilogram of weight to the limit value recommended by American Society of Parenteral and Enteral Nutrition (i.e. 2μg.kg−1 per day). Aluminium content, assessed by atomic absorption spectrophotometry, was determined in parenteral nutrition compounds and in hospital-made parenteral nutrition admixtures to clinically stable patients undergoing total or partial parenteral nutrition. Aluminium concentration in fourteen parenteral nutrition compounds and all parenteral nutrition admixtures excessed 25μg/L. Furthermore, two thirds of patients were exposed to a rate of aluminium significantly upper than that recommended by the American Society of Parenteral and Enteral Nutrition (i.e. 2μg.kg-1 per day). This study shows that parenteral nutrition compounds and parenteral nutrition admixtures were overloaded in aluminium. A monograph specifying acceptable aluminium content of parenteral nutrition products seems necessary for further redaction of European pharmaceutical norm or guidance.

Parenteral nutrition mixtures prepared at home by trained parents are as safe as pharmacy-made mixtures: A 3-y prospective study

ObjectivesHome parenteral nutrition (HPN) prevents malnutrition in children with intestinal failure improving chances for the best possible physical development and quality of life. For organizational reasons, in Poland the majority of children on HPN receive nutrition mixtures prepared at home by their parents. The aim of this study was to evaluate whether this method influences the frequency of catheter-related bloodstream infections (CRBSIs). MethodsThe aim of this prospective study was to assess the incidence of CRBSIs from January 2008 to December 2010 in 181 children on HPN and to compare the incidence in two subgroups of these children: group Ph (pharmacy) consisting of 43 patients receiving mixtures prepared in the hospital pharmacy weekly, and group H (home)—138 patients receiving nutrition mixtures prepared daily at home by their caregivers. Central venous CRBSIs were diagnosed by the presence of clinical signs (such as fever, chills, malaise, vomiting) associated with positive blood culture from the central catheter. ResultsFrom 2008 to 2010 parenteral nutrition was administrated during 128 905 catheter-days in 181 patients, and CRBSIs occurred 129 times (1 episode per 1000 catheter-days) in 65 patients. There were 42 bloodstream infections in group Ph during 29 225 catheter-days (i.e., 1.43 per 1000 catheter-days), whereas 87 bloodstream infections occurred in group H during 100 775 catheter-days (i.e., 0.86 per 1000 catheter-days; P = 0.0516). ConclusionsPreparing parenteral nutrition mixtures at home by trained parents is a safe method of HPN with a slightly (however insignificantly) lower incidence of CRBSIs compared with hospital pharmacy-prepared parenteral nutrition mixtures.

GRP-090 Implementation of Gravimetric Analysis in the Pharmacy Department

BackgroundParenteral nutrition (PN) involves multicomponent intravenous mixtures of high complexity and is considered a high-risk medicine. Monitoring systems are needed to reduce the morbidity and mortality of patients receiving PN.Purpose...

Exploring ripening of nanocapsules and Émulsions in parenteral nutritional mixtures by experimental design

Lipid nanocapsules based on vegetal oils (vo-LNC) can be prepared and used to allow both the easy incorporation of oils in the aqueous phase and the stability of mixtures for parenteral nutrition. In this context of use, vo-LNC was shown an interesting process of ripening. To explore this ripening process, experimental design was used. The same mixture design was performed for both the incorporation of lipids by vo-LNC as by emulsion. The responses chosen for the experimental design was the average size and zeta potential of both. As expected, vo-LNC and emulsion were affected at different level by the ripening process. This indicates clearly that vo-LNC would permit the early incorporation of lipids in parenteral nutrition admixtures without any risk of instability and can be safely administered for parenteral use.

Test de dépyrogénation des conteneurs en inox et en verre pour la préparation des mélanges pour nutrition parentérale

The preparation of parenteral nutrition mixture (PNM) in an open chamber requires the use of intermediate containers sterile and non-pyrogenic. A sterilization of containers by moist heat in large autoclaves is the suitable method. However, sterilization by moist heat is not a depyrogenation method. In our study, we report the validation of a sterilization and depyrogenation method for containers by dry heat using a convection oven. Sterilization and depyrogenation of material by dry heat have been audited by the reduction of at least three logarithms of original endotoxin rate. The containers were initially artificially contaminated with a suspension of endotoxin for 16 hours. Contaminated containers were placed in an oven with revolving heat at 250 °C for 1 hour. After treatment with dry heat, the residual endotoxin levels in the containers were determined by a kinetic chromogenic method. After treatment with dry heat, the average log reductions of endotoxin levels were respectively, for glass and steel containers, 4.78 ± 0.07 and 4.87 ± 0.03. The present validation study confirms the effectiveness of treatment with dry heat for sterilization and depyrogenation of glass and steel containers. This method of sterilization and depyrogenation meets the microbiological quality requirements for the preparation of MNP.

Treatment of Hypertriglyceridemia in Patients Receiving Parenteral Nutrition

This study aims to evaluate whether withdrawal of a soy oil-based lipid emulsion from the parenteral nutrition (PN) regimen in humans is associated with improved triglyceride and liver enzyme concentrations. In this retrospective study, patients with hypertriglyceridemia (>4.50 mmol/L) while receiving PN were retrieved from a prospective complication registration database. Patients received Intralipid 20% as part of an all-in-one system containing all necessary macro- and micronutrients, electrolytes, trace elements, and vitamins. Forty patients with hypertriglyceridemia were included. Lipid emulsions were withdrawn from the all-in-one mixture for a median of 5 (range, 1-23) days, after which triglyceride concentrations decreased significantly (mean difference -2.5 ± 0.30 mmol/L, P < .001). Aspartate aminotransaminase and leukocyte count decreased significantly (mean difference -35 ± 17 U/L, P = .049 and -3.8 ± 1.7*10E9/L, P = .028, respectively), whereas albumin level increased significantly (mean difference 2.1 ± 0.9 g/L, P = .027). Alanine aminotransaminase showed a nonsignificant reduction (mean difference -30 ± 22 U/L, P = .194). In 11 patients, the lipid emulsion was reintroduced, after which triglyceride levels showed a significant increase (mean difference 1.5 ± 0.30 mmol/L, P = .001). Short-term withdrawal of the lipid fraction in the PN mixture is associated with a significant reduction of plasma triglyceride concentration. Reintroduction was related to an increase of triglyceride concentration. In addition, liver enzyme abnormalities and leukocyte count reduced, whereas albumin levels increased, suggesting that even short withdrawal of the lipid emulsion diminished hepatocellular damage and systemic inflammation.