Intravenous supplementation type and volume are associated with 1-year outcome and major complications in patients with chronic intestinal failure.

BACKGROUND AND AIM: No marker to categorise the severity of chronic intestinal failure (CIF) has been developed. A 1-year international survey was carried out to investigate whether the European Society for Clinical Nutrition and Metabolism clinical classification of CIF, based on the type and volume of the intravenous supplementation (IVS), could be an indicator of CIF severity. METHODS: At baseline, participating home parenteral nutrition (HPN) centres enrolled all adults with ongoing CIF due to non-malignant disease; demographic data, body mass index, CIF mechanism, underlying disease, HPN duration and IVS category were recorded for each patient. The type of IVS was classified as fluid and electrolyte alone (FE) or parenteral nutrition admixture (PN). The mean daily IVS volume, calculated on a weekly basis, was categorised as <1, 1-2, 2-3 and >3 L/day. The severity of CIF was determined by patient outcome (still on HPN, weaned from HPN, deceased) and the occurrence of major HPN/CIF-related complications: intestinal failure-associated liver disease (IFALD), catheter-related venous thrombosis and catheter-related bloodstream infection (CRBSI). RESULTS: Fifty-one HPN centres included 2194 patients. The analysis showed that both IVS type and volume were independently associated with the odds of weaning from HPN (significantly higher for PN <1 L/day than for FE and all PN >1 L/day), patients' death (lower for FE, p=0.079), presence of IFALD cholestasis/liver failure and occurrence of CRBSI (significantly higher for PN 2-3 and PN >3 L/day). CONCLUSIONS: The type and volume of IVS required by patients with CIF could be indicators to categorise the severity of CIF in both clinical practice and research protocols.

Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research.

BACKGROUND: Immunonutrition is assumed to enhance immune system function. In surgical patients, it is supposed to reduce postoperative complications. However, results of recent clinical trials have been puzzling and have not supported this theory. AIM: The aim of our study was to evaluate the value of enteral and parenteral postoperative immunonutrition. METHODS: After initial evaluation of 969 patients, the intent-to-treat analysis included 776 patients (female 407, male 466, mean age 61.1 years) undergoing gastric or pancreatic resections between 2001 and 2009. All patients were randomly assigned after surgery to one of the following groups: standard enteral nutrition (SEN), immunomodulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), or immunomodulating parenteral nutrition (IMPN). All malnourished patients received preoperative parenteral nutrition. Number and type of postoperative complications, length of hospitalization (length of stay [LOS]), and vital organ function were assessed. RESULTS: No statistically significant differences were observed in well-nourished patients, during either enteral or parenteral intervention, independent of the type of intervention (standard or immunomodulating). However, analysis of the malnourished group revealed the positive impact of enteral immunonutrition on reduction of postoperative complications (28.3 vs. 39.2 %, respectively; p = 0.043) and LOS (17.1 and 13.1 days, respectively; p < 0.05) compared with a standard enteral diet. The cross-analysis of SEN, IMEN, SPN, and IMPN was insignificant. CONCLUSIONS: The type of postoperative nutrition was of no importance in well-nourished patients. However, in malnourished patients, enteral immunonutrition helped to improve treatment outcome. These findings suggest its use as a method of choice during the postoperative period.

Patients' and caregivers' perspective on challenges and outcomes with tube feeding: Analysis of home enteral nutrition survey data.

BACKGROUND: Given the growing use of home enteral nutrition (HEN), assessing the experience of consumers and caregivers is crucial to understanding the real-world subjective and objective challenges of administering HEN. METHODS: After obtaining institutional review board approval, a survey was distributed to HEN consumers and caregivers between January 16, 2020, and July 16, 2021. Data collected included information regarding demographics, primary diagnosis, tube and connectors, HEN regimen, and overall HEN experience. RESULTS: A total of 884 individuals responded to the survey: 673 (76.1%) responses by caregivers and 211 (23.9%) responses by patients. The study cohort included 566 (64%) children and 318 (36%) adults. The leading primary diagnosis of participants was developmental delay and motility disorder for children and adults, respectively. Low-profile gastric tubes were the most used (75.7% of children and 30.3% of adults). Notably, legacy connectors were utilized for more patients (46.7% children, 52.6% adults) compared to ISO-80369-3 connectors (38.9% children, 29.7% adults). HEN complications were prevalent, including enteral tube site infections and other tube-related complications, including clogging and kinking. CONCLUSION: This real-world data reveals that HEN complications remain prevalent. Additionally, despite introducing ISO-80369-3 connectors many years ago, most patients continue to use legacy tubes with a significant lack of knowledge about ISO-80369-3 connectors. The survey results guide HEN providers to focus on several areas to reduce complications.

ESPEN guideline on chronic intestinal failure in adults - Update 2023.

BACKGROUND & AIMS: In 2016, ESPEN published the guideline for Chronic Intestinal Failure (CIF) in adults. An updated version of ESPEN guidelines on CIF due to benign disease in adults was devised in order to incorporate new evidence since the publication of the previous ESPEN guidelines. METHODS: The grading system of the Scottish Intercollegiate Guidelines Network (SIGN) was used to grade the literature. Recommendations were graded according to the levels of evidence available as A (strong), B (conditional), 0 (weak) and Good practice points (GPP). The recommendations of the 2016 guideline (graded using the GRADE system) which were still valid, because no studies supporting an update were retrieved, were reworded and re-graded accordingly. RESULTS: The recommendations of the 2016 guideline were reviewed, particularly focusing on definitions, and new chapters were included to devise recommendations on IF centers, chronic enterocutaneous fistulas, costs of IF, caring for CIF patients during pregnancy, transition of patients from pediatric to adult centers. The new guideline consist of 149 recommendations and 16 statements which were voted for consensus by ESPEN members, online in July 2022 and at conference during the annual Congress in September 2022. The Grade of recommendation is GPP for 96 (64.4%) of the recommendations, 0 for 29 (19.5%), B for 19 (12.7%), and A for only five (3.4%). The grade of consensus is "strong consensus" for 148 (99.3%) and "consensus" for one (0.7%) recommendation. The grade of consensus for the statements is "strong consensus" for 14 (87.5%) and "consensus" for two (12.5%). CONCLUSIONS: It is confirmed that CIF management requires complex technologies, multidisciplinary and multiprofessional activity, and expertise to care for the underlying gastrointestinal disease and to provide HPN support. Most of the recommendations were graded as GPP, but almost all received a strong consensus.

Experience and opinions relating to pregnancy in patients with chronic intestinal failure: an international survey.

Introduction: Pregnancy in patients with chronic intestinal failure (CIF) is a relatively rare occurrence but is an important contemporary topic given both the increasing use of home parenteral nutrition (HPN) and the demographics of patients with CIF. Method: An opinion-based survey was produced in a multidisciplinary manner, which was then distributed internationally, via the European Society for Clinical Nutrition and Metabolism network, using a web-based survey tool for healthcare professionals with a specialist interest in the management of CIF. Results: Seventy specialists from 11 countries completed the survey. Fifty-four per cent of the respondents reported some experience of managing pregnancy in patients with CIF. However, 60% stated that they did not feel that it was their role to discuss the topic of pregnancy with their patients, with fewer than 10% stating that they routinely did so. Respondents felt that an individualised approach was required when considering alterations to parenteral support prior to conception, during pregnancy and in the postnatal period. Most respondents also felt there was no increased risk of catheter-related blood stream infections, while catheter-related thrombosis was deemed to be the most significant HPN-related complication for pregnant women. Conclusion: This study reports a variable experience, knowledge and confidence of healthcare professionals when considering pregnancy in patients with CIF. The risk of HPN-related complication was felt to be greater during pregnancy, with an individualised approach being the preferred route for most aspects of care. The findings support the need for an international registry and subsequent consensus guidelines for the management of pregnancy in CIF.

A multi-national survey of experience and attitudes towards managing catheter related blood stream infections for home parenteral nutrition.

BACKGROUND AND AIMS: Catheter-related bloodstream infection (CRBSI) is the most common complication of home parenteral nutrition (HPN) in patients with chronic intestinal failure (CIF). The aim of this study was to assess the broad range of practices of international multi-disciplinary teams involved in the care of this complication occurring in CIF patients. DESIGN: An online questionnaire was designed and distributed to members of the European Society for Clinical Nutrition and Metabolism (ESPEN) and distributed to colleagues involved in managing patients with CIF. RESULTS: A total of 47 responses were included from centers across 21 countries. The centers had been delivering HPN for a median 21 years (IQR 11-35) and were actively following a median 58 patients (27-120) per center for benign CIF in 80% of cases (67-95). Tunneled catheters were the most common type of central venous catheters (CVC), representing 70% (47-86) of all CVC in use. For the management of CRBSI, written procedures were provided in 87% of centers. First measures included simultaneous central and peripheral blood cultures (90%), stopping HPN infusion (74%), and administrating an antibiotic lock and systemic antibiotics (44%). Immediate removal of the CVC was more likely in case of fungal infection (78%), Staphylococcus aureus (53%), or in case of PICC catheter (52%) (all p < 0.01). After the first CRBSI, 80% of centers used preventive CVC locks (taurolidine in 84% of cases, p < 0.001). We observed a large heterogeneity in practices regarding preparation, duration, reaspiration, and volume of CVC locks, and monitoring of CRBSI (timing of blood cultures, radiological work-up). CONCLUSION: In this international survey of HPN expert centers, we observed a significant consensus regarding the initial management of CRBSI and the use of secondary preventive CVC locks, while areas of variation exist. Management of CRBSI may be improved with clearer recommendations based on the micro-organism and the type of CVC, including PICC lines which are increasingly used yet insufficiently studied in HPN patients.

Enteral and parenteral nutrition in the conservative treatment of pancreatic fistula: a randomized clinical trial.

BACKGROUND & AIMS: Postoperative pancreatic fistula is the most common and potentially life-threatening complication after pancreatic surgery. Although nutritional support is a key component of conservative therapy in such cases, there have been no well-designed clinical trials substantiating the superiority of either total parenteral nutrition or enteral nutrition. This study was conducted to compare the efficacy and safety of both routes of nutritional intervention. METHODS: A randomized clinical trial was conducted in a tertiary surgical center of pancreatic and gastrointestinal surgery. Seventy-eight patients with postoperative pancreatic fistula were treated conservatively and randomly assigned to groups receiving for 30 days either enteral nutrition or total parenteral nutrition. The primary end point was the 30-day fistula closure rate. RESULTS: After 30 days, closure rates in patients receiving enteral and parenteral nutrition were 60% (24 of 40) and 37% (14 of 38), respectively (P=.043). The odds ratio for the probability that fistula closes on enteral nutrition compared to total parenteral nutrition was 2.571 (95% confidence interval [CI]: 1.031-6.411). Median time to closure was 27 days (95% CI: 21-33) for enteral nutrition, and no median time was reached in total parenteral nutrition (P=.047). A logistic regression analysis identified only 2 factors significantly associated with fistula closure, ie, enteral nutrition (odds ratio=6.136; 95% CI: 1.204-41.623; P=.043) and initial fistula output of ≤200 mL/day (odds ratio=12.701; 95% CI: 9.102-47.241; P<.001). CONCLUSIONS: Enteral nutrition is associated with significantly higher closure rates and shorter time to closure of postoperative pancreatic fistula.

Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: Results after 5 y of home parenteral nutrition.

OBJECTIVES: Intravenous lipid emulsions (ILE) are an essential component of parenteral nutrition (PN); however, pure soybean oil emulsion is considered a risk factor for intestinal failure-associated liver disease (IFALD). Limited data are available on the effect of different ILEs on the liver during long-term PN, and to our knowledge, no study has evaluated outcomes beyond 12 mo. Therefore, the aim of the present study was to assess the influence of mixed ILEs on liver function during long-term PN. METHODS: A randomized, open-label clinical trial was performed at the Intestinal Failure Center in Skawina, Poland. Sixty-seven patients (35 F, 32 M; mean age, 53.2 years) receiving home parenteral nutrition (HPN) due to stable chronic intestinal failure (CIF) were randomized to receive one of the following three ILEs: medium/long-chain triacylglycerides (MCT/LCT), olive oil/soybean oil (OO/SO), or a combination of SO/MCT/OO/fish oil (FO) (SMOFlipid). Patients were followed for 5 y. Liver function was assessed clinically and with biochemical parameters (total bilirubin, serum glutamyl oxalate transaminase, serum glutamyl pyruvate transaminase, γ-glutamyl transpeptidase, and alkaline phosphatase) at baseline and after 24 and 60 mo. RESULTS: The most common etiology for CIF was vascular, followed by Crohn's disease, surgical complications, and radiation enteritis. HPN was effective in improving nutritional status and was associated with low rates of catheter infections and clinical complications. No significant differences were observed between groups in median concentrations serum glutamyl oxalate transaminase, serum glutamyl pyruvate transaminase, γ-glutamyl transpeptidase, or alkaline phosphatase at 24 or 60 mo. A significant reduction in median bilirubin concentration was observed in the SMOFlipid group at 60 mo compared with baseline (6.8 umol/L; interquartile range, 5.2-8.5 versus 7.7 umol/L; interquartile range, 4.9-12.4; P = 0.0138). CONCLUSIONS: Mixed ILEs are safe and effective for use in patients on long-term HPN. A multicomponent ILE with FO can provide additional benefits in terms of liver function during long-term HPN.

From hospital unit to intestinal failure center: Twenty years of history.

AIM: Home parenteral nutrition (HPN) is one of the most demanding medical therapies as it is the only option for patients for intestinal failure (IF). No unequivocal policy on how to start and progress with HPN has ever been presented. The IF Center at the Stanley Dudrick's Memorial Hospital in Skawina is one of the biggest centers in Poland, celebrating its twentieth birthday last year. It offered the unique chance to present how to create and grow the IF center, increasing the quality of care. The above became the aim of this study. METHODS: A retrospective analysis of all medical records of HPN patients from the University Hospital and Stanley Dudrick's Memorial Hospital in Skawina. Patient profile, clinical course and treatment outcomes were assessed. The evolution of all aspects of HPN is presented. A brief historical perspective has been added to better illustrate the center's growth and transformation. RESULTS: 608 patients (363 female, 245 male, mean age 55.55 year) from all over Poland were treated between December 1999 and December 2019. The most frequent indication for HPN was mechanical obstruction (277, 45.7%), followed by short bowel syndrome (SBS, 208, 34.3%) and intestinal fistula (46, 7.59%). The most common primary disease was cancer (n = 267), followed by mesenteric ischemia (n = 104), and surgical complications (n = 62). 314 patients (51.8%) died. 73 (12.04%) were successfully weaned off PN. The catheter infection rate reached 0.39/1000 catheter days. CONCLUSIONS: the founding of the HPN center and its further development is possible provided that there is team of dedicated people, supported by hospital base. The real growth opportunity is guaranteed by the reimbursement. It is necessary to adapt to the changing circumstances.

Enhanced Recovery after Surgery (ERAS) Protocol Is a Safe and Effective Approach in Patients with Gastrointestinal Fistulas Undergoing Reconstruction: Results from a Prospective Study.

BACKGROUND AND AIMS: An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of the ERAS protocol in surgical patients with ECF. METHODS: ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 females, 56 males, mean age 54.1 years) were evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed. Registered under ClinicalTrials.gov Identifier no. NCT04771832. RESULTS: ERAS protocol was successfully introduced for ECF surgeries; however, eight modifications to the ERAS program was performed in 2015. They led to improvement of surgical outcomes: reduction of postoperative nausea and vomiting (15 vs. 17% patients, p = 0.025), overall complication rate (11 vs. 10, p = 0.021), median length of hospital stay (overall and after surgery, p = 0.022 and 0.002, respectively). CONCLUSIONS: ERAS protocol can be successfully used for ECF patients. Prescheduled audits can contribute to the improvement of care.

ESPEN practical guideline: Clinical nutrition in chronic intestinal failure.

BACKGROUND: This practical guideline is based on the ESPEN Guidelines on Chronic Intestinal Failure in Adults. METHODOLOGY: ESPEN guidelines have been shortened and transformed into flow charts for easier use in clinical practice. The practical guideline is dedicated to all professionals including physicians, dieticians, nutritionists, and nurses working with patients with chronic intestinal failure. RESULTS: This practical guideline consists of 112 recommendations with short commentaries for the management and treatment of benign chronic intestinal failure, including home parenteral nutrition and its complications, intestinal rehabilitation, and intestinal transplantation. CONCLUSION: This practical guideline gives guidance to health care providers involved in the management of patients with chronic intestinal failure.

Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey.

BACKGROUND AND AIMS: The case-mix of patients with intestinal failure due to short bowel syndrome (SBS-IF) can differ among centres and may also be affected by the timeframe of data collection. Therefore, the ESPEN international multicenter cross-sectional survey was analyzed to compare the characteristics of SBS-IF cohorts collected within the same timeframe in different countries. METHODS: The study included 1880 adult SBS-IF patients collected in 2015 by 65 centres from 22 countries. The demographic, nutritional, SBS type (end jejunostomy, SBS-J; jejuno-colic anastomosis, SBS-JC; jejunoileal anastomosis with an intact colon and ileocecal valve, SBS-JIC), underlying disease and intravenous supplementation (IVS) characteristics were analyzed. IVS was classified as fluid and electrolyte alone (FE) or parenteral nutrition admixture (PN). The mean daily IVS volume, calculated on a weekly basis, was categorized as <1, 1-2, 2-3 and >3 L/day. RESULTS: In the entire group: 60.7% were females and SBS-J comprised 60% of cases, while mesenteric ischaemia (MI) and Crohn' disease (CD) were the main underlying diseases. IVS dependency was longer than 3 years in around 50% of cases; IVS was infused ≥5 days/week in 75% and FE in 10% of cases. Within the SBS-IF cohort: CD was twice and thrice more frequent in SBS-J than SBS-JC and SBS-JIC, respectively, while MI was more frequent in SBS-JC and SBS-JIC. Within countries: SBS-J represented 75% or more of patients in UK and Denmark and 50-60% in the other countries, except Poland where SBS-JC prevailed. CD was the main underlying disease in UK, USA, Denmark and The Netherlands, while MI prevailed in France, Italy and Poland. CONCLUSIONS: SBS-IF type is primarily determined by the underlying disease, with significant variation between countries. These novel data will be useful for planning and managing both clinical activity and research studies on SBS.

High Dose Intravenous Fish Oil Reduces Inflammation-A Retrospective Tale from Two Centers.

AIM: Patients on parenteral nutrition (PN) are prone to inflammation. This may aggravate an existing proinflammatory state and become a critical factor in the development of liver dysfunction (LD). Intravenous fish oil may attenuate this inflammatory state, but data on its use in adults are scarce. The aim of this study was to investigate the effects of adding a pure fish oil intravenous lipid emulsion (ILE) into short- and long-term PN in patients either at risk of, or with existing, inflammation. METHODS: A retrospective analysis of 61 patients (32 female, 29 male, mean age 51.5 ± 12.6 years) who received all-in-one PN, including amino acids, glucose, and lipids supplemented with pure fish oil ILE, was performed. Pure fish oil ILE (Omegaven®, Fresenius Kabi, Bad Homburg, Germany) was used along with the standard ILE to reach a fish oil dose of 0.4-0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n = 20), Crohn's disease (CD, n = 22), and ulcerative colitis (UC, n = 19). The observation period was 12 months for CIF and 21 days for UC and CD. RESULTS: A reduction in inflammation was noticeable in all patients and became statistically significant in CD (hsCRP p < 0.0001, ESR p = 0.0034, procalcitonin p = 0.0014, Il-6 p = 0.001) and UC groups (hsCRP and ESR p < 0.0001, Il-6 p = 0.0001, TNF-α p = 0.0113). In the CIF group, the total bilirubin concentration (p = 0.2157) and aspartate transaminase SGOT (p = 0.1785) did not vary over time. CONCLUSIONS: PN with pure fish oil ILE reduces some inflammatory parameters in IBD and maintains liver function parameters in CIF patients. Fish oil might become a valuable ingredient in both short- and long-term PN in patients at risk of liver dysfunction.

An international survey on clinicians' perspectives on the diagnosis and management of chronic intestinal pseudo-obstruction and enteric dysmotility.

BACKGROUND: Chronic intestinal pseudo-obstruction (CIPO) and enteric dysmotility (ED) are small intestinal motility disorders defined by radiological and manometric criteria. In the absence of consensus guidelines, we surveyed opinions on the diagnosis and management of CIPO and ED among experts from different countries. METHODS: A survey questionnaire was circulated electronically to members of the European society for Clinical Nutrition and Metabolism, European Society of Neurogastroenterology and Motility, and United European Gastroenterology. Only responses from participants completing all required components were included. KEY RESULTS: Of 154 participants, 93% agreed that CIPO and ED should be classified separately. Overall, 73% reported an increasing incidence of CIPO and ED, with hypermobile Ehlers-Danlos Syndrome the group with the largest increase in referrals (37%), particularly in the UK (P < .0001). The majority (95%) find diagnosing CIPO and ED difficult. Notably, antroduodenal manometry, a test mandated to diagnose ED, is infrequently used (only 21% respondents use in >50% cases) and full thickness biopsies were reported to seldom influence medical treatment, nutritional management, and prognosis. Respondents reported that very few treatments are useful for most patients, with bacterial overgrowth treatment, prucalopride, and psychological therapies felt to be the most useful. While only 23% of clinicians felt that parenteral nutrition (PN) improves gastrointestinal symptoms in >50% of cases, 68% reported PN dependency at 5 years in the majority of cases. CONCLUSIONS AND INFERENCES: These data highlight the difficulties with diagnosing and managing CIPO and ED and underscore the urgent need for international, multidisciplinary, clinical practice guidelines.

Considerations for the management of home parenteral nutrition during the SARS-CoV-2 pandemic: A position paper from the Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN.

The management of patients with chronic intestinal failure requiring home parenteral nutrition has been and will continue to be impaired during the SARS-CoV-2 pandemic. Multidisciplinary intestinal failure teams may have to adapt their clinical approaches to home care, outpatient care as well as hospital admission and discharge in order to keep this vulnerable group of patients as safe and well as possible during the unprecedented challenges that countries are facing during the pandemic. Equally, it is important that expert advice from intestinal failure teams is available when home parenteral nutrition (HPN)-dependent patients require admission with SARS-CoV-2 infection. The Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of the European Society for Clinical Nutrition and Metabolism (ESPEN) has developed a position paper to outline areas for intestinal failure teams to consider when managing patients with chronic intestinal failure during the SARS-CoV-2 pandemic.

Home medical nutrition during SARS-CoV-2 pandemic - A position paper.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a worldwide rapidly spreading illness, Coronavirus Disease 2019 (COVID-19). Patients fed enterally and parenterally at home are exposed to the same risk of infection as the general population, but more prone to complications than others. Therefore the guidance for care-givers and care-takers of these patients is needed. METHODS: The literature search identified no relevant systematic reviews or studies on the subject. Therefore a panel of 21 experts from 13 home medical nutrition (HMN) centres in Poland was formed. Twenty-three key issues relevant to the management of SARS-CoV-2 infection or COVID-19 in the HMN settings were identified and discussed. Some statements diverge from the available nutrition, surgical or ICU guidelines, some are based on the best available experience. Each topic was discussed and assessed during two Delphi rounds subsequently. Statements were graded strong or weak based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. RESULTS: the panel issued 23 statements, all of them were graded strong. Two scored 85.71% agreement, eleven 95.23%, and ten 100%. The topics were: infection control, enrolment to HMN, logistics and patient information. CONCLUSIONS: the position paper present pragmatic statements for HMN to be implemented in places without existing protocols for SARS-CoV-2 pandemic. They represent the state of knowledge available at the moment and may change should new evidence occurs.

Home parenteral nutrition provision modalities for chronic intestinal failure in adult patients: An international survey.

BACKGROUND & AIMS: The safety and effectiveness of a home parenteral nutrition (HPN) program depends both on the expertise and the management approach of the HPN center. We aimed to evaluate both the approaches of different international HPN-centers in their provision of HPN and the types of intravenous supplementation (IVS)-admixtures prescribed to patients with chronic intestinal failure (CIF). METHODS: In March 2015, 65 centers from 22 countries enrolled 3239 patients (benign disease 90.1%, malignant disease 9.9%), recording the patient, CIF and HPN characteristics in a structured database. The HPN-provider was categorized as health care system local pharmacy (LP) or independent home care company (HCC). The IVS-admixture was categorized as fluids and electrolytes alone (FE) or parenteral nutrition, either commercially premixed (PA) or customized to the individual patient (CA), alone or plus extra FE (PAFE or CAFE). Doctors of HPN centers were responsible for the IVS prescriptions. RESULTS: HCC (66%) was the most common HPN provider, with no difference noted between benign-CIF and malignant-CIF. LP was the main modality in 11 countries; HCC prevailed in 4 European countries: Israel, USA, South America and Oceania (p < 0.001). IVS-admixture comprised: FE 10%, PA 17%, PAFE 17%, CA 38%, CAFE 18%. PA and PAFE prevailed in malignant-CIF while CA and CAFE use was greater in benign-CIF (p < 0.001). PA + PAFE prevailed in those countries where LP was the main HPN-provider and CA + CAFE prevailed where the main HPN-provider was HCC (p < 0.001). CONCLUSIONS: This is the first study to demonstrate that HPN provision and the IVS-admixture differ greatly among countries, among HPN centers and between benign-CIF and cancer-CIF. As both HPN provider and IVS-admixture types may play a role in the safety and effectiveness of HPN therapy, criteria to homogenize HPN programs are needed so that patients can have equal access to optimal CIF care.

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.

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: 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: 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: ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial.

BACKGROUND AND AIM: Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients. MATERIAL AND METHODS: Between June 1, 2001, and December 31, 2005, a group of 214 well-nourished patients was initially assessed (150 men, 64 women, mean age 61.2 years) to participate in the study. Nine patients were subsequently excluded and the remaining 205 subjects were randomly assigned in a 2 x 2 factorial design into 4 study groups, ie, standard enteral nutrition (n = 53), immunomodulating enteral nutrition (n = 52), standard parenteral nutrition (n = 49), and immunomodulating enteral nutrition (n = 51). The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. The study was registered in the Clinical Trials Database-number NCT 00558155. RESULTS: The overall morbidity rate was 33% and the incidence of individual complications was comparable between all groups. Infectious complications occurred in 26 of 102 patients given standard diets and in 22 of 103 patients receiving immunomodulatory formulas (odds ratio 0.81; 95% CI, 0.43-1.50). There were no significant differences between infectious complications in patients using parenteral nutrition (22 of 100 patients) and parenteral formulas (26 of 105, odds ratio 1.14; 95% CI, 0.61-2.14). Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures, including overall morbidity and mortality rates, and hospital stay. CONCLUSIONS: Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery. Both enteral and parenteral treatment options showed similar efficacy, tolerance, and effects on protein synthesis. Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition. However, because of its cost-efficiency, enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy.

Denosumab Improves Bone Mineral Density in Patients With Intestinal Failure Receiving Home Parenteral Nutrition: Results From a Randomized, Controlled Clinical Trial.

AIM: Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D, and bisphosphonates have been used to treat BMD but with low efficiency due to their limited absorption and patient compliance. Denosumab is a new drug that helps prevent osteoclast development and activation and led to decreased bone resorption in some studies. The aim of this study was to assess its value in HPN patients. METHODS: Between November 2011 and March 2013, 49 patients receiving HPN (29 women, 20 men, mean age 55.3 years) who met the eligibility criteria were randomly assigned to a denosumab or control group. Regional dual-energy x-ray absorptiometry of the spine and hip was performed before therapy and after 12 months. BMD, T score, and z score were assessed. RESULTS: Fifteen patients received 2 doses of therapy and were fully reassessed after 1 year. At baseline and after 12 months, the absorptiometry revealed T scores of -3.439 standard deviations (SD) vs -2.33 SD at lumbar segment 2 (L2) and -2.957 SD vs -2.067 SD at lumbar segment 3 (L3), z scores of -2.24 SD vs -1.36 SD at L2 and -1.995 vs -1.067 SD at L3, and BMD of 0.801 vs 0.946 at L2 and 0.857 vs 0.979 at L3, respectively. Two serious outcomes were reported, without any correlation to the intervention. Two patients were weaned off HPN and hence discontinued. One patient experienced sciatica, resulting in discontinuation of the intervention. CONCLUSIONS: This study showed that denosumab may be a valuable treatment option for improving BMD in HPN patients.