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Pharmacoeconomics of Parenteral Nutrition with ω-3 Fatty Acids in Hospitalized Adults
Pradelli, Lorenzo; Muscaritoli, Maurizio; Klek, Stanislaw; Martindale, Robert G
The inclusion of ω-3 fatty acids as part of parenteral nutrition is associated with clinical benefits such as a reduced likelihood of infectious complications and shorter hospital and intensive care unit (ICU) stays. As healthcare resources are limited, pharmacoeconomic analyses have been performed, typically modeling studies, using cost and outcomes data to investigate the cost-effectiveness of parenteral nutrition regimens including ω-3 fatty acids from fish oil compared with standard parenteral nutrition without such ω-3 fatty acids. This review covers pharmacoeconomic studies encompassing Italian, French, German, and UK hospitals for ICU and non-ICU hospitalized patients, and for ICU patients in China. The results show that the use of parenteral nutrition including ω-3 fatty acids more than offsets any additional acquisition costs in all national scenarios investigated to date, indicating that parenteral nutrition including ω-3 fatty acids is a clinically and economically beneficial strategy compared with standard parenteral nutrition.
PMID: 32049391
ISSN: 1941-2444
CID: 5411502
Use of Lipids in Adult Patients Requiring Parenteral Nutrition in the Home Setting
Mundi, Manpreet S; Klek, Stanislaw; Martindale, Robert G
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.
PMID: 32049397
ISSN: 1941-2444
CID: 5411552
Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects
Boullata, Joseph I; Berlana, David; Pietka, Magdalena; Klek, Stanislaw; Martindale, Robert
A number of topics important to the handling of intravenous lipid emulsions (ILEs) were discussed at the international summit. ILE handling includes the preparation and the administration steps in the typical use of parenteral nutrition (PN). The discussion and consensus statements addressed several issues, including standardization of the PN process, use of commercially available multi-chamber PN or compounded PN bags, the supervision by a pharmacist with expertise, limiting ILE repackaging, and infusion duration.
PMID: 32049398
ISSN: 1941-2444
CID: 5411562
Lipid Use in Hospitalized Adults Requiring Parenteral Nutrition
Mayer, Konstantin; Klek, Stanislaw; García-de-Lorenzo, Abelardo; Rosenthal, Martin D; Li, Ang; Evans, David C; Muscaritoli, Maurizio; Martindale, Robert G
In hospitalized patients, lipid emulsions are an integral part of balanced parenteral nutrition. Traditionally, a single lipid source, soybean oil, has been given to patients and was usually regarded as just a source of energy and to prevent essential fatty-acid deficiency. However, mixtures of different lipid emulsions have now become widely available, including mixtures of soybean oil, medium-chain triglycerides, olive oil, and fish oil. Fish oil is high in the ω-3 polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). There is a growing body of evidence that these ω-3 fatty acids can exert beneficial immunomodulatory, anti-inflammatory, and inflammation-resolution effects across a wide range of patient groups including surgical, cancer, and critically ill patients. At least in part, these effects are realized via potent specialized pro-resolution mediators (SPMs). Moreover, parenteral nutrition including ω-3 fatty acids can result in additional clinical benefits over the use of standard lipid emulsions, such as reductions in infection rates and length of hospital and intensive care unit stay. Clinical and experimental evidence is reviewed regarding lipid emulsion use in a variety of hospitalized patient groups, including surgical, critically ill, sepsis, trauma, and acute pancreatitis patients. Practical aspects of lipid emulsion use in critically ill patients are also considered, such as how to determine and fulfill energy expenditure, how and when to consider parenteral nutrition, duration of infusion, and safety monitoring.
PMID: 32049396
ISSN: 1941-2444
CID: 5411542
Acute intestinal failure: International multicenter point-of-prevalence study
Reintam Blaser, Annika; Ploegmakers, Ilse; Benoit, Michael; Holst, Mette; Rasmussen, Henrik Hojgaard; Burgos, Rosa; Forbes, Alastair; Shaffer, Jon; Gabe, Simon; Irtun, Oivind; Thibault, Ronan; Klek, Stanislaw; Olde Damink, Steven Wm; van de Poll, Marcel; Panisic-Sekeljic, Marina; Wanten, Geert; Pironi, Loris
BACKGROUND & AIMS:Intestinal failure (IF) is defined from a requirement or intravenous supplementation due to failing capacity to absorb nutrients and fluids. Acute IF is an acute, potentially reversible form of IF. We aimed to identify the prevalence, underlying causes and outcomes of acute IF. METHODS:This point-of-prevalence study included all adult patients hospitalized in acute care hospitals and receiving parenteral nutrition (PN) on a study day. The reason for PN and the mechanism of IF (if present) were documented by local investigators and reviewed by an expert panel. RESULTS:Twenty-three hospitals (19 university, 4 regional) with a total capacity of 16,356 acute care beds and 1237 intensive care unit (ICU) beds participated in this study. On the study day, 338 patients received PN (21 patients/1000 acute care beds) and 206 (13/1000) were categorized as acute IF. The categorization of reason for PN was revised in 64 cases (18.9% of total) in consensus between the expert panel and investigators. Hospital mortality of all study patients was 21.5%; the median hospital stay was 36 days. Patients with acute IF had a hospital mortality of 20.5% and median hospital stay of 38 days (P > 0.05 for both outcomes). Disordered gut motility (e.g. ileus) was the most common mechanism of acute IF, and 71.5% of patients with acute IF had undergone abdominal surgery. Duration of PN of ≥42 days was identified as being the best cut-off predicting hospital mortality within 90 days. PN ≥ 42 days, age, sepsis and ICU admission were independently associated with 90-day hospital mortality. CONCLUSIONS:Around 2% of adult patients in acute care hospitals received PN, 60% of them due to acute IF. High 90-day hospital mortality and long hospital stay were observed in patients receiving PN, whereas presence of acute IF did not additionally influence these outcomes. Duration of PN was associated with increased 90-day hospital mortality.
PMID: 30683610
ISSN: 1532-1983
CID: 5411392
ω-3 Fatty-Acid Enriched Parenteral Nutrition in Hospitalized Patients: Systematic Review With Meta-Analysis and Trial Sequential Analysis
Pradelli, Lorenzo; Mayer, Konstantin; Klek, Stanislaw; Omar Alsaleh, Abdul Jabbar; Clark, Richard A C; Rosenthal, Martin D; Heller, Axel R; Muscaritoli, Maurizio
This systematic review and meta-analysis investigated ω-3 fatty-acid enriched parenteral nutrition (PN) vs standard (non-ω-3 fatty-acid enriched) PN in adult hospitalized patients (PROSPERO 2018 CRD42018110179). We included 49 randomized controlled trials (RCTs) with intervention and control groups given ω-3 fatty acids and standard lipid emulsions, respectively, as part of PN covering ≥70% energy provision. The relative risk (RR) of infection (primary outcome; 24 RCTs) was 40% lower with ω-3 fatty-acid enriched PN than standard PN (RR 0.60, 95% confidence interval [CI] 0.49-0.72; P < 0.00001). Patients given ω-3 fatty-acid enriched PN had reduced mean length of intensive care unit (ICU) stay (10 RCTs; 1.95 days, 95% CI 0.42-3.49; P = 0.01) and reduced length of hospital stay (26 RCTs; 2.14 days, 95% CI 1.36-2.93; P < 0.00001). Risk of sepsis (9 RCTs) was reduced by 56% in those given ω-3 fatty-acid enriched PN (RR 0.44, 95% CI 0.28-0.70; P = 0.0004). Mortality rate (co-primary outcome; 20 RCTs) showed a nonsignificant 16% reduction (RR 0.84, 95% CI 0.65-1.07; P = 0.15) for the ω-3 fatty-acid enriched group. In summary, ω-3 fatty-acid enriched PN is beneficial, reducing risk of infection and sepsis by 40% and 56%, respectively, and length of both ICU and hospital stay by about 2 days. Provision of ω-3-enriched lipid emulsions should be preferred over standard lipid emulsions in patients with an indication for PN.
PMCID:7003746
PMID: 31250474
ISSN: 1941-2444
CID: 5411442
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
Klek, Stanislaw; Chambrier, Cécile; Cooper, Sheldon C; Gabe, Simon; Kunecki, Marek; Pironi, Loris; Rahman, Farooq; Sobocki, Jacek; Szczepanek, Kinga; Wanten, Geert; Lincke, Nicole; Glotzbach, Bernhard; Forbes, Alastair
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. Intravenously administered 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/DESIGN/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 8 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 the safety and tolerability as well as the efficacy of the ILEs. DISCUSSION/CONCLUSIONS: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 working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.
PMCID:6938010
PMID: 31888740
ISSN: 1745-6215
CID: 5411462
Investigating Risk Factors for Complications after Ileostomy Reversal in Low Anterior Rectal Resection Patients: An Observational Study
Rubinkiewicz, Mateusz; Witowski, Jan; Wysocki, Michał; Pisarska, Magdalena; Kłęk, Stanisław; Budzyński, Andrzej; Pędziwiatr, Michał
PMCID:6832752
PMID: 31581485
ISSN: 2077-0383
CID: 5411452
An international study of the quality of life of adult patients treated with home parenteral nutrition
Baxter, Janet P; Fayers, Peter M; Bozzetti, Federico; Kelly, Darlene; Joly, Francisca; Wanten, Geert; Jonkers, Cora; Cuerda, Cristina; van Gossum, Andre; Klek, Stanislaw; Boudreault, Marie-France; Gilbert, Alain; Jobin, Manon; Staun, Michael; Gillanders, Lyn; Forbes, Alastair; O'Callaghan, Margie; Faedo, Ceferino Martínez; Brunelli, Cinzia; Mariani, Luigi; Pironi, Loris
BACKGROUND & AIMS:in a multinational sample of adult patients; to provide a description of QOL dimensions by short and long HPN treatment duration; to explore clinical factors potentially associated to QOL scores. METHODS:. The questionnaires were analysed to evaluate data completeness, convergent/discriminant validity and internal-consistency reliability. The association of overall QOL and HPN treatment duration as well as other clinical factors were investigated using multivariable linear regression models. RESULTS:in the different English, French and Italian language patient sub-groups confirmed psychometric equivalence of the three questionnaire versions. The results of the multivariable linear regression showed that QOL scores were significantly associated with HPN duration (better in long-term), underlying disease (better in Crohn's disease and mesenteric ischaemia) and living status (worse in living alone) and, after adjusting for the other factors, with the number of days of HPN infusion per week. CONCLUSIONS:, is a valid tool for measurement of QOL in patients on HPN, to be used in the clinical practice as well as in research.
PMID: 30115461
ISSN: 1532-1983
CID: 5411362
Commentary on "Fish Oil-Containing Lipid Emulsions in Adult Parenteral Nutrition: A Review of the Evidence" [Comment]
Adolph, Michael; Calder, Philip C; Deutz, Nicolaas E; Carmona, Teodoro Grau; Klek, Stanislaw; Lev, Shaul; Mayer, Konstantin; Michael-Titus, Adina T; Pradelli, Lorenzo; Puder, Mark; Singer, Pierre; Vlaardingerbroek, Hester
PMID: 29603280
ISSN: 1941-2444
CID: 5411342