Parenteral Nutrition Bags Research Articles

Phthalate exposure induces cell death and ferroptosis in neonatal microglial cells.

Phthalates are the materials used for plasticizing polyvinyl chloride. Di-(2-Ethylhexyl) phthalate (DEHP) is one of the phthalates most frequently used in a wide range of applications, including medical equipment such as endotracheal and feeding tubes, intravenous catheters, central lines, extracorporeal membrane oxygenation sets, total parenteral nutrition bags, blood product sets, and intravenous pump lines, respiratory sets in neonatal intensive care units (NICUs). Studies have shown that phthalates, including DEHP, can cross the placenta and blood-brain barrier, possibly leading to neurodevelopmental impairment in vitro and in vivo. However, the molecular mechanisms affected by phthalate exposure have not been explored in depth. This study aimed to illuminate the effects of DEHP on neuroinflammation at the molecular level using neonatal microglial cells as the model. Mouse BV-2 neonatal microglia cells were exposed to DEHP under controlled conditions. Cellular toxicity was assessed via a cell viability assay and specific markers were used to evaluate the apoptosis/necrosis, cellular iron content, reactive oxygen species (ROS), and organelle integrity. Proinflammatory proteins were quantified using enzyme-linked immunosorbent assay, while ferroptosis was assessed using a ferroptosis blocker, and affected gene expressions were determined using quantitative reverse-transcriptase real-time polymerase chain reaction (RT-PCR). The results revealed that high concentrations of DEHP exposure increased toxicity via increased levels of ROS and inflammation. Elevated ROS levels were observed to increase the tendency for mitochondrial-lysosomal disruption, bringing about apoptosis or necrosis. Moreover, iron homeostasis was dysregulated by DEHP, which putatively triggered ferroptosis in a dose-dependent manner. This study indicates that neonatal exposure to DEHP may be linked to neurodevelopmental impairment via inflammation-related cell death and ferroptosis. The prevalence of DEHP in NICU medical devices raises concerns about potential neurodevelopmental deficits, including disorders like autism and mental retardation. These findings highlight the urgency of addressing DEHP exposure in neonatal care.

Multi-chamber parenteral nutrition (PN) bags are safe and cost-effective in replacing compounded PN regimens in hospitalised patients

Background & AimsThere is varied international practice in the use of ready-made multi-chamber bags (MCBs) and compounded parenteral nutrition (PN). Recent national aseptic pharmacy capacity limitations have restricted compounded PN production so we aimed to explore outcomes associated with the increased use of MCB vs compounded regimens during a period of change in PN supplies. MethodsThis was a point prevalence study conducted over two time periods, Period 1: 01.01.2022 – 31.03.2022 and Period 2: 01.10.2022 – 31.12.2022. Data were collected on PN regimen, outcomes, cost and aseptic time required to prepare PN bags. Results263 patients were included: 132 in Period 1 and 131 in Period 2. Overall, 2263 PN bags were utilised; 1179 in Period 1 and 1084 in Period 2. In Period 1, of all utilised bags, 138 (11.7%) were compounded PN, 356 (30.2%) supplemented MCBs and 685 (58.1%) manipulated MCBs whereas in Period 2, 0 were compounded PN, 546 (50.3%) supplemented MCBs and 538 (49.6%) manipulated MCBs. There were no significant differences in the proportion of patients with deranged blood tests between the study periods. In both periods there were only two episodes of catheter-related blood stream infection. The total cost saved in Period 2 compared to Period 1 was £20,684 and total aseptic staff time saved was 191 hours. ConclusionWider use of in-hospital MCB PN regimens could lead to a reduction in the need for compounded PN produced by aseptic pharmacy facilities, saving costs while maintaining good patient outcomes.

Parenteral nutrition in clinical practice: International challenges and strategies.

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. 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. 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.

Biochemical test as an efficient system to improve safety in parenteral nutrition for premature infants

ObjectiveThe biochemical test validation process of parenteral nutrition bags is described to verify the correct composition of critical compounds before its administration, as well as its impact on safety after two years since its implantation in a population of premature infants. MethodFor the validation of the technique, 35 samples of parenteral nutrition without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in plasma and urine. To analyze its impact on safety, pre-implantation and post-implantation risk analysis was carried out using failure mode, effects and criticality analysis (FMECA). Likewise, all out-of-range results and their potential repercussions on patient safety were evaluated. ResultsRegression analysis showed no systematic measurement error for glucose, calcium and potassium; however, there is a constant systematic error for sodium and magnesium, thus both were discarded for routine analysis. Failure mode, effects and criticality analysis results showed a decrease in the risk of the process of 11% for the biochemical test. We tested 1,734 parenteral nutritions from 218 premature neonates; 58 (3.3%) results were out of the acceptance range, and 7 were considered to be potentially dangerous compounding errors. ConclusionsThe biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching the patient.

Capillary electrophoresis in parenteral nutrition control – validation of two analytical methods: Amino acids/glucose/glucose-1-phosphate and K/Na/Ca/Mg

ObjectivesProduction of parenteral nutrition bags (PNBs) involves many nutrients: complete control of the production process decreases the risk of error. This study aimed to develop and validate two analytical methods...

Rapid implementation of an emergency on-site CKRT dialysate production system during the COVID-19 pandemic

BackgroundOn December 29, 2021, during the delta wave of the Coronavirus Disease 2019 (COVID-19) pandemic, the stock of premanufactured solutions used for continuous kidney replacement therapy (CKRT) at the University of New Mexico Hospital (UNMH) was nearly exhausted with no resupply anticipated due to supply chain disruptions. Within hours, a backup plan, devised and tested 18 months prior, to locally produce CKRT dialysate was implemented. This report describes the emergency implementation and outcomes of this on-site CKRT dialysate production system.MethodsThis is a single-center retrospective case series and narrative report describing and reporting the outcomes of the implementation of an on-site CKRT dialysate production system. All adults treated with locally produced CKRT dialysate in December 2021 and January 2022 at UNMH were included. CKRT dialysate was produced locally using intermittent hemodialysis machines, hemodialysis concentrate, sterile parenteral nutrition bags, and connectors made of 3-D printed biocompatible rigid material. Outcomes analyzed included dialysate testing for composition and microbiologic contamination, CKRT prescription components, patient mortality, sequential organ failure assessment (SOFA) scores, and catheter-associated bloodstream infections (CLABSIs).ResultsOver 13 days, 22 patients were treated with 3,645 L of locally produced dialysate with a mean dose of 20.0 mL/kg/h. Fluid sample testing at 48 h revealed appropriate electrolyte composition and endotoxin levels and bacterial colony counts at or below the lower limit of detection. No CLABSIs occurred within 7 days of exposure to locally produced dialysate. In-hospital mortality was 81.8% and 28-day mortality was 68.2%, though illness severity was high, with a mean SOFA score of 14.5.ConclusionsThough producing CKRT fluid with IHD machines is not novel, this report represents the first description of the rapid and successful implementation of a backup plan for local CKRT dialysate production at a large academic medical center in the U.S. during the COVID-19 pandemic. Though conclusions are limited by the retrospective design and limited sample size of our analysis, our experience could serve as a guide for other centers navigating similar severe supply constraints in the future.

Stability Testing of Modified Amino Acid Solutions in Neonatal Parenteral Nutrition Formulations

ABSTRACT Context: Aqueous neonatal parenteral nutrition (PN) formulations are made up of glucose, amino acids (AAs), and electrolytes. Different AA solutions are used to make these formulations. Most licensed products do not meet the nutritional needs of preterm neonates specifically for arginine. Therefore, AA solutions with additional arginine need to be developed and proven stable before being tested for clinical efficacy. PN formulations containing modified AA solutions with 15% arginine were tested in this study. Aims: This study aims to design a stability testing protocol and assign a shelf life to the modified PN formulations being tested. Methods: Physical tests including appearance, pH, optical rotation, ultraviolet absorbance, and subvisible particle count tests as well as chemical analysis using AA assay were performed in this study. Results: Resampling of PN bag samples posed a risk for oxidation and hence single sampling of fresh PN bags for each test point is the best practice for PN stability testing trials. AA assay is a feasible method to ensure AA stability in PN formulations. Conclusion: Modified PN formulations with 15% arginine were stable for 90 days without the addition of the trace element solution. Upon the addition of trace elements, the shelf life was limited to 7 days.

Carbohydrates Induce Liver Test Disturbances During Treatment Of Critically Ill Patients With Triple Chamber Parenteral Nutrition Bags, Even With Disturbed Liver Test At Start. Lipids And Proteins Don't.

Carbohydrates Induce Liver Test Disturbances During Treatment Of Critically Ill Patients With Triple Chamber Parenteral Nutrition Bags, Even With Disturbed Liver Test At Start. Lipids And Proteins Don't.

Implementation of a parenteral nutrition home care programme in a tertiary hospital.

the objective of this study was to describe the results of the implementation of a home parenteral nutrition (HPN) care programme (Nutrihome©) in a cohort of patients treated at a tertiary hospital. retrospective study of the patients included in Nutrihome© at Hospital General Universitario Gregorio Marañón, Madrid, Spain. Nutrihome consists of different modules including pre-discharge nursing hospital visits and nursing home visits, deliveries of the infusion pump, consumables and parenteral nutrition bags, patient training, weekly scheduled nursing home visits, scheduled nursing phone calls, stock control phone calls and 24-hour on-call line manned by the nurses. the study included 8 (75 % women) and 10 (70 % women) patients in the Nutrihome© pilot and Nutrihome© programme, respectively. A total 37 adverse events were reported during Nutrihome© pilot, 26 of which were technical, 9 clinical, 1 was catheter-related and 1 other event. Nutrihome© programme registered a total of 107 adverse events reported, 57 of which were technical, 21 clinical, 16 were catheter-related and 13 were other events. A total of 99 % of these events were solved by Nutrihome© via phone calls or home visits. Nutrihome© programme has been extremely useful during this pandemic, facilitaing both the start of HPN and training at the patient home without the need for hospitalisation. Additionally, the adverse events reported and solved by Nutrihome© not only reduced the physicians' burden during those tough times and the patients´ stress of being hospitalised during a pandemic, but supported the entire healthcare system.

Glycemic Management of Hospitalized Patients Receiving Nutrition Support.

Enteral nutrition (EN) and parenteral nutrition (PN) increase the risk of hyperglycemia and adverse outcomes, including mortality, in patients with and without diabetes. A blood glucose target range of 140-180 mg/dL is recommended for hospitalized patients receiving artificial nutrition. Using a diabetes-specific EN formula, lowering the dextrose content, and using a hypocaloric PN formula have all been shown to prevent hyperglycemia and associated adverse outcomes. Insulin, given either subcutaneously or as a continuous infusion, is the mainstay of treatment for hyperglycemia. However, no subcutaneous insulin regimen has been shown to be superior to others. This review summarizes the evidence on and provides recommendations for the treatment of EN- and PN-associated hyperglycemia and offers strategies for hypoglycemia prevention. The authors also highlight their institution's protocol for the safe use of insulin in the PN bag. Randomized controlled trials evaluating safety and efficacy of targeted insulin therapy synchronized with different types of EN or PN delivery are needed.

A quality by design approach for the qualification of automating compounding device for parenteral nutrition

Automated compounding device (ACD) are increasingly used for parenteral nutrition (PN) bag production, and their acquisition must be sufficiently thought. The law requires the qualification of these ACD, but did not specify the tests to be performed. The quality by design (QbD) risk based approach allowed to define the quality target product profile in order to acquire the best ACD for each unit, and thanks a risk analysis permitted to define the critical quality attributes (CQA). These CQA will allowed to define tests performed during qualification. The ACD qualified was a 12 pump volumetric system. The CQA for PN bags consisted in sterile, precisely and accurately production with enough stability. During operational qualification volumetric accuracy test was performed, and during the performance qualification: flush volume, media fill, microbiological integrity of environment, sterility of control bag and production test were performed. At the end, all tests were conclusive (excepted for some results mostly due to analytical bias) and the ACD was considered to produce sterile bags in a control environment, precisely (relative standard deviation < 4%) and accurately (mean bias < 1% for weight and < 7% for other controls) with a sufficient stability. The QbD risk based approach allowed to acquire the best ACD for our need, and qualify relevant elements regarding the production process.

Optimisation of an inpatient parenteral nutrition formulary in a secondary care hospital

Compounding units, both in hospital aseptic units and nationally, are under significant pressure.1 This has led to a national drive to standardise prescribing of parenteral nutrition (PN). The aim is to reduce the need for custom, bespoke bags and maximise the use of standard multi-chamber PN. Nutritional requirements recommended by PENG also changed in 20182- both of these factors led to the critical evaluation of the suitability of inpatient parenteral nutrition bag range on the hospital formulary.

Management of Hyperglycemia in Hospitalized Patients Receiving Parenteral Nutrition.

Almost half of inpatients on parenteral nutrition experience hyperglycemia, which increases the risk of complications and mortality. The blood glucose target for hospitalized patients on parenteral nutrition is 7.8 to 10.0 mmol/L (140 to 180 mg/dL). For patients with diabetes, the same parenteral nutrition formulae as for patients without diabetes can be used, as long as blood glucose levels can be adequately controlled using insulin. Insulin can be delivered via the subcutaneous or intravenous route or, alternatively, added to parenteral nutrition admixtures. Combining parenteral with enteral and oral nutrition can improve glycemic control in patients with sufficient endogenous insulin stores. Intravenous insulin infusion is the preferred route of insulin delivery in critical care as doses can be rapidly adjusted to altered requirements. For stable patients, insulin can be added directly to the parenteral nutrition bag. If parenteral nutrition is infused continuously over 24 hours, the subcutaneous injection of a long-acting insulin combined with correctional bolus insulin may be adequate. The aim of this review is to give an overview of the management of parenteral nutrition-associated hyperglycemia in inpatients with diabetes.

Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests

ObjectivesAutomation of parenteral nutrition (PN) preparation is nowadays a recommended practice in order to reduce human errors and thus improve the safety and accuracy of the finished product. Other benefits...

Ventrikulo-peritoneal Şantlı Çocukta Serratia Spp. Menenjiti

Serratia species are opportunistic, gram-negative, motile bacteria classified in the large family Enterobacteriaceae and differentiate from Klebsiella spp. with slow fermenting lactose and DNAase positive (1,2). One of the characteristics of Serratia bacteria that distinguishes them from other bacteria is to synthesize the red pigments, prodigiosins. It can cause nosocomial infections especcialy in newborns and patients in intensive care units. Serratia spp.; responsible for approximately 2% of nosocomial infections; has been reported as the responsible agent especially in respiratory tract infections, urinary tract infections and bacteremia. An outbreak of S. marcescens blood stream infection has been identified in patients receiving contaminated parenteral nutrition bags (2). It has been reported to cause S. marcescens meningitis, wound infections, arthritis and outbreaks in pediatric wards (3). In this text we aimed to present a three and a half year old girl case of acute bacterial meningitis due to Serratia spp. with ventriculo-peritoneal shunt.

Quantitative analysis on bioavailability of insulin in bags of parenteral nutrition

Rationale: Hyperglycemia is reported in more than 50% of patients receiving parenteral nutrition (PN).A gold standard for the administration of insulin in PN solutions does not exist due to its unknown bioavailability. We performed a quantitative analysis of insulin bioavailability in the main types of PN bags, analysing the matrix and time effects, as well as the effect related to the presence of vitamin supplements.

Addition of Regular Insulin to Ternary Parenteral Nutrition: A Stability Study.

sBackground: Parenteral nutrition (PN) is a complex medium in which added insulin can become unstable. The aim of this study is, therefore, to evaluate the stability of insulin in PN and to identify influencing factors. Methods: A total of 20 IU/L of regular insulin was added to PN in either glass or Ethylene Vinyl Acetate (EVA) containers. A 24 h stability study was performed via an electrochemiluminescence immunoassay in different media: A ternary PN admixture, separate compartments of the PN bag and a binary admixture. This study was repeated in the absence of zinc, with the addition of serum albumin or tween and with pH adjustment (3.6 or 6.3). Insulin concentration at t time was expressed as a percentage of the initial insulin concentration. Analysis of covariance (ANCOVA) was applied to determine the factors that influence insulin stability. Results: In all PN admixtures, the insulin concentration ratio decreased, stabilising at a 60% and then plateauing after 6 h. At pH 3.6, the ratio was above 90%, while at pH 6.3 it decreased, except in the amino acid solution. ANCOVA (r2 = 0.68, p = 0.01) identified dextrose and pH as significant factors influencing insulin stability. Conclusion: A low pH level seems to stabilise insulin in PN admixtures. The influence of dextrose content suggests that insulin glycation may influence stability.

Dosage of sodium and potassium in paediatric parenteral nutrition bags: Using an automated system for physicochemical control

Summary Introduction Validate an analytical method for the determination of Sodium and Potassium in parenteral nutrition bags by indirect potentiometry using correction factors; and evaluate routine control results. Material and methods An analytical method of dosage of electrolytes by Cobas Integra 400 Plus® analyzer was validated using the SFSTP guidelines. Bags of matrix admixtures were prepared for validation; electrolytes were added at different concentrations. We studied the linearity, accuracy and precision. The validated method was used to assess the conformity of electrolytes concentrations within the parenteral nutrition bags. The acceptance limit for conformity assessment was set at ± 20% of the target concentration. Results Correlation coefficients of the regression lines were higher than 0.999. The method showed good repeatability and intermediate precision (RSD Discussion Non-conformity is increased by increasing the total volume and exceeding the theoretical capacity of the bag. The extension of the mixing time significantly increases the conformity rate. Conclusion A laboratory analyzer provides a valid and precise method for the determination of electrolytes in parenteral nutrition bags. A proper mixing is critical in order to obtain exact determination results.

Influence of different lipid emulsions on specific immune cell functions in head and neck cancer patients receiving supplemental parenteral nutrition: An exploratory analysis

ObjectivesThe effect of diet on immune responses is an area of intense investigation. Dietary lipids have been shown to differently influence and fine-tune the reactivity of immune cell subsets, thus potentially affecting clinical outcomes. Patients with head and neck squamous cell carcinoma face malnutrition, due to swallowing impairment related to the tumor site or to treatment sequalae, and may need supplemental parenteral nutrition (SPN) in addition to oral feeding when enteral nutrition is not feasible. Additionally, immune depression is a well-known complication in these patients. Parenteral nutrition (PN) bags contain amino acids, minerals, electrolytes and mostly lipids that provide calories in a concentrated form and are enriched with essential fatty acids. The aim of this study was to investigate multiple parameters of the immune responses in a cohort of patients with head and neck squamous cell carcinoma undergoing supplemental PN with bags enriched in ω-3 or ω-9 and ω-6 fatty acids. MethodsTo our knowledge, this was the first exploratory study to investigate the effects of two different PN lipid emulsions on specific immune cells function of patients with advanced head and neck squamous carcinoma. ω-3-enriched fish-oil-based- and ω-6- and ω-9-enriched olive-oil-basedSPN was administered to two groups of patients for 1 wk in the context of an observational multicentric study. Polychromatic flow cytometry was used to investigate multiple subsets of leukocytes, with a special focus on cellular populations endowed with antitumor activity. ResultsPatients treated with olive-oil-based PN showed an increase in the function of the innate (natural killer cells and monocytes) and adaptive (both CD4 and CD8 cells) arms of the immune response. ConclusionAn increase in the function of the innate and adaptive arms of the immune response may favor antitumoral responses.

An International Survey of Clinicians' Experience Caring for Patients Receiving Home Parenteral Nutrition for Chronic Intestinal Failure During the COVID-19 Pandemic.

BackgroundThis survey of centers caring for patients receiving home parenteral nutrition (HPN) was conducted to assess the impact of the coronavirus disease 2019 (COVID‐19) crisis on the management of these patients regarding provision of care, monitoring, regular follow‐up, and any changes to service infrastructure.MethodsA survey was devised and publically published on the Research Electronic Data Capture database management system, with individual centers responding to a public link.ResultsA total of 78 adult and pediatric centers worldwide contributed to the survey, representing ≥3500 patients’ experiences. Centers reported infrastructure maintenance for Parenteral Nutrition (PN) bag deliveries to patients (60, 76.92%) or delivery of ancillary items (57, 73.08%), home delivery and HPN administration (65, 83.33%), and home care nurse shortages (25, 32.05%). Routine follow‐up of HPN patients changed to either all telemed or mixed with emergency clinic review (70, 89.74%). In 26 centers (33.33%), HPN for newly discharged patients with benign conditions was reduced or stopped. Based on clinical history, the centers reported psychological distress for patients (52, 66.67%), with anxiety, worry, concern, and apprehension reported most frequently (37 of 52, 71.15%) but also fear (10 of 52, 19.23%), depression (5 of 52, 9.62%), and issues related to isolation/confinement (12 of 52, 23.08%).ConclusionsThe COVID‐19 pandemic was reported by clinicians to have had a far‐reaching adverse impact on patients receiving HPN, especially their safety in terms of provision of personal protective equipment, PN bags, available nursing staff, and psychological well‐being. Healthcare systems responded to the challenge and presented new ways of working.