Introduction
Nutritional support for individuals with conditions requiring long-term intravenous nutrition can be challenging, as providing adequate nutrition can be difficult when dealing with limited nutritional options available through enteral nutrition or enteral tube feedings. Total parenteral nutrition (TPN) has become an important part of the nutritional support of these patients in recent years. Although the use of TPN has been increasing, concerns have emerged regarding how to provide a balanced formulation and reduce the risk of complications or adverse consequences. One area of particular concern is providing an adequate lipids source for these patients.
This paper will examine the various strategies for providing lipids in TPN in home infusion patients and compare the outcomes for lipid emulsions in different formulations and delivery systems. Home infusion is defined as providing intravenous nutrition at home, as opposed to inpatient settings, including home healthcare delivery and institutional delivery, such as nursing homes. Specifically, this paper will compare and contrast the effectiveness and safety outcomes of lipid emulsions and their delivery systems among home infusion patients receiving TPN.
Problem Description
Home infusion services are utilized by many people who suffer from severe intestinal malabsorption, such as short bowel syndrome (SBS), intestinal failure-associated liver disease (IFALD) secondary to short bowel syndrome, cystic fibrosis, Crohn’s Disease, Enteropathies, and other conditions which involve malabsorption, to ensure proper sustenance of nutrition (Aksan et al., 2021). Such individuals necessitate frequent commensurate monitoring of their nutritional status, where a major component of their daily intravenous TPN formulation comprises lipid emulsions; these emulsions need to be supplied in aseptic levels for optimum nutrient intake. To understand better the efficacy of home infusion services for the aforementioned malabsorptive syndromes, pertinent sub-topics may include an evaluation of the specific requirements for nutrient absorption in SBS patients, the importance of parenteral nutrition and lipid emulsions for sustaining individuals with malabsorption and their qualitative analysis, as well as exploring the avenues to maximize efficient nutrient utilization while ensuring adherence to safety parameters. It is key to analyze how these components work in synergy to effectively reach optimal levels of nourishment and wellbeing in patients undergoing home infusion services (Lowe, 2020). To this end, one may evaluate various studies in medical literature to elucidate further how this treatment protocol operates at different capacities for different conditions and the efficacy of parenteral nutrition and lipid emulsions for nutrient absorption by SBS patients. Additionally, qualitative approaches for investigative evaluation of the efficacy of parenteral nutrition and lipid emulsions for those with malabsorption can also be discussed. Furthermore, approaches for efficient nutrient use by patients undergoing home infusion services, such as dietary management and lifestyle change, can also be explored.
However, the delivery of lipids via TPN has presented certain dangers which may induce complications if not managed effectively. For instance, if a patient receives too much fat or oil-based lipid emulsion, this can lead to elevated triglyceride levels or even fat overload syndromes, such as hyperviscosity or HTGP. This risk is further compounded by the potential for hypersensitivity reactions due to many lipids’ bioactive components, such as omega-3 polyunsaturated fatty acids (PUFAs), phytosterols, and the added Vitamin E. Such an overload of lipids may sound alarming; however, any potential toxicity from a TPN program can be well contained when appropriately managed. The introduction of too much fat into the diet can be detected quickly and monitored through biochemical parameters such as blood triglycerides. Hyperviscosity and its associated HTGP are most commonly seen with prolonged high doses of TPN containing large amounts of fat emulsion. It is imperative to monitor the lipid emulsion in the TPN mixture, with particular attention to the amounts taken in. One way to minimize any potential adverse effects is to slowly increase the doses of TPN over time and monitor the Total Essential Fatty Acid intake levels relative to caloric intake.
Hypersensitivity reactions due to elements within TPN mixtures are also a concern that should be closely monitored by healthcare provider personnel (Boullata et al., 2021). These occur more rarely than the more common occurrences of fat overload syndromes and have been detected in children and adults who have been administered TPN containing PUFAs. High amounts of Vitamin E. Prompt protocols for discontinuing TPN and replacing it with another form of nutrition delivery should be swiftly enacted upon clinical observation or any suspicion of an allergic reaction or hypersensitivity response resulting from its bioactive components.
Lastly, because TPN is generally utilized for those with a compromised gastrointestinal system and those in long-term treatment, there is also an increased risk for infection from any foreign object administered intravenously through their central veins. ASEPSIS protocol should be strictly adhered to when administering TPN continuously in order to reduce any potential entry points for microorganisms into the bloodstream as much as possible, as well as performing comprehensive tests prior to each dose to determine any contamination or toxicity levels present prior to infusion (Sastry & Deepashree, 2019). The danger that may arise following the administration of lipids via TPN can be effectively managed by healthcare personnel if they are mindful of all the necessary parameters to keep in check throughout the process of administering these compounds, thus ensuring an optimal nutritional delivery system without exposing patients to unnecessary danger or risk (Caro‐Bautista et al., 2021).
Available Knowledge
The administration of lipid emulsions as part of Total Parenteral Nutrition (TPN) is complex, requiring careful consideration of the multiple components involved in formulating an effective emulsion. Previous clinical studies have extensively explored the effects of intravenous lipids and their associated benefit in specific indications. These research studies have indicated that certain formulations of lipids, such as those with omega-3 polyunsaturated fatty acids (PUFAs), phytosterols, Vitamin E or other antioxidants, may be particularly beneficial. Omega-3 PUFAs present in many lipid emulsions offer antioxidant benefits for the body, thus conferring a protective effect on cells from free radical damage and thus promoting the anti-inflammatory response. Omega-3 fatty acids also have cardiovascular benefits that may reduce the incidence of cardiovascular abnormalities and mortality (Djuricic & Calder, 2021). Phytosterols are plant-derived sterols commonly found in vegetable oils. They have been proposed as useful components of lipid emulsions due to their potential role in regulating inflammation and enhancing immune functions. Vitamin E is an important antioxidant, which scavenge free radicals present in lipid emulsions and provides protective effects against oxidative damage.
Selecting an adequately balanced emulsion is crucial for optimal TPN effects. Studies have shown that excessive and prolonged exposure to intravenous lipids or fat overload can disrupt normal cell physiology, causing inflammation and microvascular dysfunction in multiple organs and leading to other complications such as impaired hepatic glucose metabolism, disruption of tissue lipids, and increased morbidity. Additionally, lipid emulsions are thought to influence how some drugs are delivered and assimilated within the body and thus should be used cautiously in patients taking certain pharmaceuticals. It is also important to consider the method of administration, which can include bolus infusion, manual addition during TPN preparation, infusion in a continuous lifestyle, or automated addition through a delivery system, each potentially impacting accuracy and safety of TPN delivery. Optimization of fat compositions and the dose and frequency of lipid infusion have been suggested to enhance patient outcomes and reduce potential short- and long-term complications arising from lipids infusion.
Evidence from a systematic review conducted by Pang et al. (2019) has confirmed that an adequate intake of long-chain omega-3 polyunsaturated fatty acids (PUFAs) presents a range of beneficial effects on intestinal immune functioning and a reduction in the risk of decaying health due to lower gastrointestinal tract conditions such as Crohn’s disease and ulcerative colitis. Notably, these PUFAs can provide therapeutic benefits with minimal adverse risks, providing the recommended dosages are adhered to. This is further reinforced by numerous case reports demonstrating the potential to utilize PUFAs at high dosages in certain home infusion applications without the detriment of toxicity or irritation. This further reinforces the assertion that omega-3 PUFAs have real clinical potential as an effective intervention in a range of gastrointestinal conditions whilst being of low risk to those with healthy pre-existing conditions.
Remarkably, omega-3 PUFAs have been found to possess a broad range of potential health benefits, such as maintaining ocular health, cognitive capacity, and improved mental wellbeing and promoting a balanced inflammatory response (John & Singla, 2021). Omega 3 PUFAs are, therefore, a good nutritional resource that should be addressed and are suggested to be highlighted to individuals of all age groups to enhance general wellbeing and promote gastrointestinal health.
Due to the broad evidence base supporting the use and utilization of long-chain omega 3 PUFAs for their therapeutic potential, it is generally accepted that omega 3 PUFAs should be considered when addressing a range of gastrointestinal conditions. Indeed, current Dietary and Health Guidelines often recommend an adequate intake of omega-3 PUFAs to improve overall health and wellbeing, therefore highlighting their significance. Furthermore, with widespread recognition of the risk of nutritional deficiencies, the augmented advantages of omega-3 PUFAs present an attractive and viable alternative to reduce this risk (Martucci et al., 2020).
Currently, two specialized fat emulsions available under prescription for adult use with Total Parenteral Nutrition (TPN) – Nutrilipids® (Fresenius Kabi) and SMOFlipids® (Fresenius Kabi) – are proving to be particularly beneficial in providing balanced nutrition with a low concentration of several compound groups, including omega-3 fatty acids, phytosterols, minerals and vitamins. Known to be associated with an improvement in metabolic control and a decreased risk of antibiotic resistance in medical populations, these formulations represent an advancement in the field of parenteral nutrition. By providing high-quality fat emulsions in addition to other sources of carbohydrates and proteins, patients receiving TPN can gain access to a broader range of nutrients and prevent nutritional deficiencies. Furthermore, the presence of essential micronutrients, including vitamins, minerals and trace elements, contributes significantly to the quality of overall nutrition; this is further reinforced by the fact that phytosterol – a compound found in plants that demonstrates anti-inflammatory properties – has been included in low concentration to mitigate the effect of chylomicron formation from long-chain fatty acids. Finally, omega-3 fatty acids – another group of essential fatty acids also found in smaller concentrations in both formulations – offer additional benefits as part of a healthy eating pattern for adults, especially when it comes to cardiovascular health. As a result, these parenteral fat emulsions offer an advanced nutritional solution for adults receiving TPN, addressing multiple nutrition needs while minimizing potential risks.
In addition, regarding Home Infusion Patients receiving nutritional support delivered by TPN, recent work has proposed an Operational Definition which seeks to delineate more precisely the parameters under which these patients receive such support. The said definition, structured by Committee on Home Care Services (CHCS), outlines the scope and extent of management to provide parenteral nutrition support in both adult home healthcare settings and those employed in institutional or nursing home settings. This definition posits a heightened level of observation and evaluation to take place prior to offering nutritional assistance via TPN, to ensure adequate preparation for the process, for example, by identifying potential issues related to metabolic balance and fluid/electrolyte levels as well as by assessing any potential side effects that could be experienced as a result of administering such nutrition (Rodenbaugh et al.,2020). Furthermore, the recommended definition accounts for patient-specific clinical factors, such as comorbid medical conditions, that should be considered when offering such support. Indeed, the structure exhibits an acute sensitivity to the multi-dimensional aspects integral to parenteral nutrition support within home settings for at-risk populations.
Finally, the definition categories TPN administration as a medical intervention requiring regular monitoring and follow-up certification from credible healthcare personnel; this view firmly signals that parenteral nutrition support in home settings should deviate from being considered a simple administrative decision-making process to one which reflects advisory consideration of professionally trained and registered healthcare personnel with the appropriate credentials to evaluate the suitability and safety of commencing nutritional support. Furthermore, by proposing a comprehensive operational framework to support the decision-making process regarding TPN administration, the proposed CHCS definition offers an enduring structure with which home care services can utilize in offering nutritional assistance to manage patient health and wellbeing wellbeing effectively (Murney et al., 2020).
Rationale
The rationale for this study arising from two sources, in aiming for a more comprehensive understanding of how different lipid fats are absorbed from TPN among Home Infusion Patients, starts from the belief that such insight could provide direction for best practices when providing intravenous TPN for those with intestinal failure disorders, as well as potentially allowing beneficial outcomes such as reduced reaction severity or improved systemic outcomes. This potential to alter standing order sets prescribed to formulate TPN across multiple institutions through informed decisions based on their level of effectiveness is what makes gaining a greater awareness of lipid fat absorption so desirable. Moreover, by understanding the varying degrees of absorption of certain fats and how they can be optimally incorporated into TPN, it may be possible to provide improved treatment plans which enhance the patient experience and improve their prognosis, as TPN plays a prime role in preventing malnourishment (Rădulescu & Lundgren, 2019). Thus, in recognizing the influences of fats on absorption, it is hopeful that solutions can be provided which accommodate both patient needs and provide what is most beneficial in terms of the efficacy of the TPN plan.
Furthermore, effective absorption of fats in TPN may indicate good nutrient delivery, as fats are essential lipids that provide a complex array of functions throughout the body. Knowledge of absorption rates and Lipid emulsion stability can bring insight into how well the nutrients are being delivered to the systemic circulation, allowing alteration to treatment plans where required and ultimately improving patient care (Manocha et al., 2022). The notion of being able to enhance or modify treatment plans is not one to be taken lightly, as it could lead to improved therapeutic outcomes through conventional therapies and rehabilitation pathways in a much more targeted and precise manner than could have been expected previously. Although this study contains a great deal of potential, it still needs to be determined how much this insight can help change patient care in the long term. However, it could be of real benefit to those with intestinal failure disorders who depend on TPN for their nourishment and care.
In order to achieve its proposed aims, this project utilizes a funnelling method of knowledge gathering grounded in the Knowledge to Action (KTA) Model developed by Graham et al., which takes into account the full spectrum from research assessments through evidence appraisal, involving a rigorous examination of the existing evidence related to the subject matter, and reaching to knowledge exchange and ultimately practice change. The KTA Model is particularly effective when used in medical decision-making, given its potential to incorporate both theories and practical applications of research data, which is why it has been adopted as the common methodology for this project. This method first involves identifying relevant case studies according to criteria set by CHCS for determining the likelihood of an occurrence of hypersensitivity and subsequently performing an evidence appraisal. This allows for an understanding of how likely any particular formulation may cause undue risk to inform practice decisions better. Finally, the results of this appraisal will be consolidated, along with other pertinent information, including cost considerations, to deliver a set of recommended formulations that can be used with confidence and maximum efficacy in clinical contexts.
It is important to note that this project also takes into account the impact that the cost of any given formulation may have on the results, something which was previously neglected in prior studies on this topic and which can have meaningful implications on both the safety of patients and the efficacy of treatments. This further highlights the importance of combining theory with practice to inform the delivered recommendations. For example, in cases where high-risk formulations may be necessary, consideration should be taken when deciding on the affordability of any particular option. In such cases, the evidence should strongly suggest that there is no undue risk associated with a particular formulation and that it is economically feasible to ensure the best possible outcome for patients (Temesgen et al., 2021).
Specific Aims
The specific aims of this project include the following:
- To conduct a retrospective record review evaluating levels of liver enzyme transaminases (LFTs) among Home Infusion Patients receiving different formulations over consecutive time periods is an endeavour to provide insight into the effects of these different formulations on LFT levels. Since demonstrating a direct role of the medications in causing various asthenic changes within the liver enzyme has been a difficult task, this project seeks to analyze if there are differences in LFT levels between the various home infusion patient cohorts over successive monitoring periods. Thus, it will help to uncover differences in the metabolism and effects of these medications, providing information that can help to establish pharmacokinetic relationships between drugs and metabolic changes within the body. The ultimate goal of this project is to enable clinicians to predict better and manage potential side effects related to drug therapies.
- To evaluate any hypersensitivity reactions that may be present and their severity level in home infusion patients who are receiving various formulations, an assessment of the adverse reactions must be conducted. This assessment should include reviewing medical history, physical examination, and laboratory testing to determine the patient’s pre-study baseline values and monitor for laboratory abnormalities. Additionally, interviews should be conducted with the patient and healthcare providers to determine what formulations they have received and their reactions or responses to the medications. Any adverse reactions should be reported and documented, along with all pertinent clinical data, including notes on signs and symptoms, administration site, treatment process, and outcome. Careful consideration must be taken when analyzing the data to differentiate between adverse drug reactions, non-drug related adverse events and hypersensitivity reactions to reach a definitive diagnosis.
- To robustly evaluate established models of practice used in home infusion services to identify optimal fat sources when designing and establishing Total Parenteral Nutrition (TPN) formulations, this project will make a systematic analysis of the current evidence-base, coupled with a careful evaluation of both the quality and quantity of medical professionals’ current practices. By carefully analyzing both the biomedical literature on TPN formulation and systematic reviews of therapies often employed in home infusion services, this project will attempt to clarify the factors likely to influence optimal fat source selection. Furthermore, interviews conducted among medical practitioners currently employed in home infusion services will lead to deeper insights into how decisions regarding fat sources are informed and enacted in contemporary practice. The results of this project will not only inform effective sourcing of optimal fat sources for TPN formulations and allow for the design and implementation of more structured, evidence-based practices for determining fatty acid sources in home infusion services.
- To develop comprehensive clinical practice recommendations informing the selection of optimal fat sources for use in Total Parenteral Nutrition (TPN) formulations for Home Infusion Patients suffering from intestinal failure disorders, an interdisciplinary approach should be adopted. Such an approach requires a comprehensive assessment of the patient’s nutritional needs through careful consideration of a range of clinical parameters such as pre-existing conditions, nutrition-focused physical assessment (NFPA) results, and estimated energy requirements. This approach also requires an in-depth review of current evidence from clinical studies and trials, where available, to evaluate which fat sources demonstrated the greatest efficacy for achieving positive patient outcomes. In light of potential differences between individuals, due care and consideration should be given to each patient’s specific circumstances and needs when selecting an appropriate fat source. Additionally, with limited evidence or consensus on optimal practice within the literature, recommendations should be based on reasonable conjecture and extrapolation from the best available evidence only. Alternatively, referral to an appropriate speciality dietetic service may be necessary. Once a safe and effective method of delivering nutrients to the patient’s body is identified, nutrition professionals must minimise any errors or omissions in implementing such a regimen to protect patient safety and ensure best practices are met. As such, close consultation with dietitians should be established with regular review of intervention strategies to optimize the performance of treatments moving forward.
References
Aksan, A., Farrag, K., Blumenstein, I., Schröder, O., Dignass, A. U., & Stein, J. (2021). Chronic intestinal failure and short bowel syndrome in Crohn’s disease. World Journal of Gastroenterology, 27(24), 3440.
Boullata, J. I., Mirtallo, J. M., Sacks, G. S., Salman, G., Gura, K., Canada, T., … & ASPEN Parenteral Nutrition Safety Committee. (2022). Parenteral nutrition compatibility and stability: A comprehensive review. Journal of Parenteral and Enteral Nutrition, 46(2), 273-299.
Caro‐Bautista, J., Villa‐Estrada, F., Gómez‐González, A., Lupiáñez‐Pérez, I., Morilla‐Herrera, J. C., Kaknani‐Uttumchandani, S., … & Morales‐Asencio, J. M. (2021). Effectiveness of a Diabetes Education Program based on Tailored interventions and Theory of Planned Behaviour: Cluster randomized controlled trial protocol. Journal of advanced nursing, 77(1), 427-438.
Djuricic, I., & Calder, P. C. (2021). Beneficial outcomes of omega-6 and omega-3 polyunsaturated fatty acids on human health: An update for 2021. Nutrients, 13(7), 2421.
John, R., & Singla, A. (2021). Functional foods: Components, health benefits, challenges, and major projects. DRC Sustainable Future, 2(1), 61-72.
Lowe, G. (2020). Creating healthly organizations, revised and expanded edition: Taking action to improve employee wellbeingwellbeing. University of Toronto Press.
Manocha, S., Dhiman, S., Grewal, A. S., & Guarve, K. (2022). Nanotechnology: An approach to overcome bioavailability challenges of nutraceuticals. Journal of Drug Delivery Science and Technology, 103418.
Martucci, M., Conte, M., Bucci, L., Giampieri, E., Fabbri, C., Palmas, M. G., … & Franceschi, C. (2020). Twelve-week daily consumption of ad hoc fortified milk with ω-3, D, and group B vitamins has a positive impact on inflammaging parameters: A randomized cross-over trial. Nutrients, 12(11), 3580.
Murney, M. A., Sapag, J. C., Bobbili, S. J., & Khenti, A. (2020). Stigma and discrimination related to mental health and substance use issues in primary health care in Toronto, Canada: A qualitative study. International Journal of Qualitative Studies on Health and WellbeingWellbeing, 15(1), 1744926.
Rădulescu, A., & Lundgren, S. (2019). A pharmacokinetic model of lead absorption and calcium competitive dynamics. Scientific reports, 9(1), 1-27.
Rodenbaugh, D., Vo, C. T., Redulla, R., & McCauley, K. (2020). Nursing management of hepatic encephalopathy. Gastroenterology Nursing, 43(2), E35-E47.
Sastry, S. A., & Deepashree, R. (2019). Essentials of hospital infection control. Jaypee Brothers Medical Publishers.
Temesgen, N., Chekol, B., Tamirie, T., Eshetie, D., Simeneh, N., & Feleke, A. (2021). Adult sedation and analgesia in a resource limited intensive care unit–A Systematic Review and evidence based guideline. Annals of Medicine and Surgery, 66, 102356.
write