Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial

Kłęk, Stanisław; Szczepanek, Kinga; Ścisło, Lucyna; Walewska, Elżbieta; Piętka, Magdalena; Pisarska, Magdalena; Pędziwiatr, Michał

doi:10.1016/j.nut.2018.03.008

Cited by 25 publications

(38 citation statements)

References 29 publications

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“…There was no significant difference in the amount of lipid delivered to patients across the four cohorts. At the end of 12 months of PN therapy, there was no significant difference in LFTs between the groups; however, at day zero of PN therapy, those who started the soybean/fish oil hybrid had significantly higher serum bilirubin levels, with a significant difference in baseline vs twelve month serum bilirubin …”

Section: Managementmentioning

confidence: 86%

Review article: diagnosis and management of intestinal failure‐associated liver disease in adults

Bond

Huijbers

Pironi

et al. 2019

Aliment Pharmacol Ther

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Summary Background Hepatic disturbances in the context of intestinal failure and parenteral nutrition (PN) are frequently encountered and carry a significant burden of morbidity and sometimes mortality. The term intestinal failure‐associated liver disease (IFALD) refers to liver injury due to intestinal failure and associated PN, in the absence of another evident cause of liver disease, encompassing a spectrum of conditions from deranged liver enzymes, steatosis/ steatohepatitis, cholestasis as well as progressive fibrosis, cirrhosis and end‐stage liver disease. Aims To present an up to date perspective on the diagnosis/definition, aetiologies and subsequent management of IFALD and to explore future consideration for the condition, including pharmacological therapies Results In adults using long‐term PN for benign chronic intestinal failure, 1%‐4% of all deaths are attributed to IFALD. The aetiology of IFALD is multifactorial and can be broadly divided into nutritional factors (eg lipid emulsion type) and patient‐related factors (eg remaining bowel anatomy). Given its multifaceted aetiology, the management of IFALD requires clinicians to investigate a number of factors simultaneously. Patients with progressive liver disease should be considered for combined liver‐intestine transplantation, although multivisceral grafts have a worse prognosis. However, there is no established non‐invasive method to identify progressive IFALD such that liver biopsy, where appropriate, remains the gold standard. Conclusion A widely accepted definition of IFALD would aid in diagnosis, monitoring and subsequent management. Management can be complex with a number of factors to consider. In the future, dedicated pharmacological interventions may become more prominent in the management of IFALD.

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Section: Managementmentioning

confidence: 86%

Review article: diagnosis and management of intestinal failure‐associated liver disease in adults

Bond

Huijbers

Pironi

et al. 2019

Aliment Pharmacol Ther

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“…Just one of them studied an n-3 PUFA-containing ILE [26]. In this study in 73 patients lower values of total bilirubin, alanine transaminase (ALT) and aspartate transaminase (AST) were detected after 4 weeks [27]. They showed that all four ILEs were safe and had comparable influence on liver function with a slightly better effect from OO/LCT, however recognizing some limitations in interpretation given disparate initial patient characteristics.…”

Section: Intravenous Lipid Emulsions and Liver Functionmentioning

confidence: 90%

Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

Kłęk¹,

Chambrier

Cooper

et al. 2019

Preprint

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Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenous lipid emulsions (ILEs) are an essential component of HPN providing energy and essential fatty acids, but can become a risk factor for intestinal failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.Methods The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem / Lipoplus ® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin ® MCT/LCT / Medialipide ® 20%, B. Braun Melsungen AG) for a projected period of eight weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of safety and tolerability as well as the efficacy of the ILEs.Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The aim of the HOME study is to demonstrate that the n-3 PUFA enriched ILE is safe and well tolerated especially with regard to liver function in patients requiring HPN. The study will provide data from a considerable number of CIF patients and thus contribute to broaden the present evidence on the use of ILEs in HPN.Trial registrationClinicalTrials.gov, NCT03282955, registered on September 14, 2017

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“…The authors noted that there was a slight increase in alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin in the SO ILE group, whereas the MO ILE group experienced a significant decline in all 3 of these parameters. In a follow‐up study, Klek et al randomized 88 CIF patients to 1 of 4 available ILEs (MCT/SO, OO/SO, MO, and SO), and patients were followed up for over a year . At the time of analysis, 23 patients were lost to follow‐up (4 in MCT/SO, 5 in OO/SO, 6 in MO, and 8 in SO ILE groups).…”

Section: Clinical Datamentioning

confidence: 99%

“…In a follow-up study, Klek et al randomized 88 CIF patients to 1 of 4 available ILEs (MCT/SO, OO/SO, MO, and SO), and patients were followed up for over a year. 38 At the time of analysis, 23 patients were lost to follow-up (4 in MCT/SO, 5 in OO/SO, 6 in MO, and 8 in SO ILE groups). With long-term follow-up, they noted that liver function tests tended to stabilize and improve in all 4 groups, with no significant differences.…”

Section: Clinical Datamentioning

confidence: 99%

Use of Lipids in Adult Patients Requiring Parenteral Nutrition in the Home Setting

Mundi

Kłęk²,

Martindale

2020

J Parenter Enteral Nutr

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It is estimated that over 25,000 Americans receive home parenteral nutrition (HPN), mostly because of intestinal failure (IF). Although there is significant variability in the fluid and energy needs of patients receiving HPN, intravenous lipid emulsions (ILEs) are an essential part of the macronutrient composition, serving as an excellent source of non‐protein energy, as well as supplying essential fatty acids. However, the long‐term use of ILEs in particular may be associated with some detrimental health effects, such as intestinal failure associated liver disease (IFALD). Although there is lack of unifying diagnosis, IFALD can present as cholestasis, steatosis, or fibrosis, with a prevalence that ranges between 5% and 43%. The development of IFALD tends to be multifactorial. Risk factors of IFALD can include those related to IF, inflammation/infection, and long‐term parenteral nutrition. Some studies have shown a link between development of IFALD and ILE dose, especially if the dose is >1 g/kg/d, with high ω‐6:ω‐3 polyunsaturated fatty acid (PUFA) ratio and phytosterol content being theorized as some contributing factors. Thus, efforts have been made to use alternative oils (olive oil, medium‐chain triglycerides, and fish oil) to reduce the soybean‐oil content of ILE, which tends to be high in ω‐6 PUFA and phytosterols. Although additional long‐term clinical data are emerging, this strategy, as reviewed in the current manuscript, has shown to provide some benefit in both prevention and treatment of IFALD and other sequelae of HPN.

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Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial

Abstract: All four ILEs tested may be safe even during long-term parenteral nutrition. OO/LCT may be more effective than the others, but more studies in the field are needed.

Cited by 25 publications

References 29 publications

Review article: diagnosis and management of intestinal failure‐associated liver disease in adults

Review article: diagnosis and management of intestinal failure‐associated liver disease in adults

Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

Use of Lipids in Adult Patients Requiring Parenteral Nutrition in the Home Setting

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