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.

Clinical approach to the management of Intestinal Failure Associated Liver Disease (IFALD) in adults: A position paper from the Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN.

We recommend that intestinal failure associated liver disease (IFALD) should be diagnosed by the presence of abnormal liver function tests and/or evidence of radiological and/or histological liver abnormalities occurring in an individual with IF, in the absence of another primary parenchymal liver pathology (e.g. viral or autoimmune hepatitis), other hepatotoxic factors (e.g. alcohol/medication) or biliary obstruction. The presence or absence of sepsis should be noted, along with the duration of PN administration. Abnormal liver histology is not mandatory for a diagnosis of IFALD and the decision to perform a liver biopsy should be made on a case-by-case basis, but should be particularly considered in those with a persistent abnormal conjugated bilirubin in the absence of intra or extra-hepatic cholestasis on radiological imaging and/or persistent or worsening hyperbilirubinaemia despite resolution of any underlying sepsis and/or any clinical or radiological features of chronic liver disease. Nutritional approaches aimed at minimising PN overfeeding and optimising oral/enteral nutrition should be instituted to prevent and/or manage IFALD. We further recommend that the lipid administered is limited to less than 1 g/kg/day, and the prescribed omega-6/omega-3 PUFA ratio is reduced wherever possible. For patients with any evidence of progressive hepatic fibrosis or overt liver failure, combined intestinal and liver transplantation should be considered.

A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED).

OBJECTIVES: In the largest head-to-head comparison between an oral and an intravenous (IV) iron compound in patients with inflammatory bowel disease (IBD) so far, we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia (IDA). METHODS: This prospective, randomized, comparative, open-label, non-inferiority study was conducted at 36 sites in Europe and India. Patients with known intolerance to oral iron were excluded. A total of 338 IBD patients in clinical remission or with mild disease, a hemoglobin (Hb) <12 g/dl, and a transferrin saturation (TSAT) <20% were randomized 2:1 to receive either IV iron isomaltoside 1,000 according to the Ganzoni formula (225 patients) or oral iron sulfate 200 mg daily (equivalent to 200 mg elemental iron; 113 patients). An interactive web response system method was used to randomize the eligible patient to the treatment groups. The primary end point was change in Hb from baseline to week 8. Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of -0.5 g/dl. The secondary end points, which tested for superiority, included change in Hb from baseline to weeks 2 and 4, change in s-ferritin, and TSAT to week 8, number of patients who discontinued study because of lack of response or intolerance of investigational drugs, change in total quality of life (QoL) score to weeks 4 and 8, and safety. Exploratory analyses included a responder analysis (proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks), the effect of regional differences and total iron dose level, and other potential predictors of the treatment response. RESULTS: Non-inferiority in change of Hb to week 8 could not be demonstrated. There was a trend for oral iron sulfate being more effective in increasing Hb than iron isomaltoside 1,000. The estimated treatment effect was -0.37 (95% confidence interval (CI): -0.80, 0.06) with P=0.09 in the full analysis set (N=327) and -0.45 (95% CI: -0.88, -0.03) with P=0.04 in the per protocol analysis set (N=299). In patients treated with IV iron isomaltoside 1,000, the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 (95% CI: 18.6, 78.8) with P=0.002, whereas the mean change in TSAT was lower with an estimated treatment effect of -4.4 (95% CI: -7.4, -1.4) with P=0.005, compared with patients treated with oral iron. No differences in changes of QoL were observed. The safety profile was similar between the groups. The proportion of responders with Hb ≥2 g/dl (IV group: 67%; oral group: 61%) were comparable between the groups (P=0.32). Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of >1,000 mg IV. Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein (CRP). CONCLUSIONS: We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study. Based on the dose-response relationship observed with the IV iron compound, we suggest that the true iron demand of IV iron was underestimated by the Ganzoni formula in our study. Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD.

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults.

PRECIS: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN. BACKGROUND & AIM: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). METHODS: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n = 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated. RESULTS: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03). CONCLUSIONS: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile.

Management and perception of hospital undernutrition-a positive change among Danish doctors and nurses.

BACKGROUND: Undernutrition in hospitals is a common problem associated with increased morbidity and mortality, prolonged convalescence and duration of hospital stay and increased health care costs. During recent years several initiatives have brought hospital undernutrition into focus and guidelines and standards have been published. In 1997, a questionnaire-based survey among Danish hospital doctors and nurses in selected departments concluded that clinical nutrition did not fulfil accepted standards. AIMS: We wished to determine if improvements had occurred in the intervening period. METHOD: Thus, in 2004 a similar questionnaire was sent to 4000 randomly selected Danish hospital doctors and nurses and responses were compared to those from 1997. The questionnaire dealt with attitudes and practice in the areas of nutritional screening, treatment plan, monitoring as well as with knowledge, education, tools and guidelines, organisation and possible barriers to implementation of nutritional screening and therapy. RESULTS: The overall response rate was 38%. We observed a marked improvement especially in screening procedures, calculation of energy intake in at-risk patients and local availability of guidelines. Many departments had appointed staff members with special interest and knowledge in clinical nutrition. CONCLUSION: Although significant positive changes had thus occurred, the main barriers against implementation of good nutrition care continued to be lack of knowledge, interest and responsibility, in combination with difficulties in making a nutrition plan. This will be the focus of future activities.

A method for implementation of nutritional therapy in hospitals.

BACKGROUND AND AIMS: Many barriers make implementation of nutritional therapy difficult in hospitals. In this study we investigated whether, a targeted plan made by the staff in different departments could improve nutritional treatment within selected quality goals based on the ESPEN screening guidelines. METHODS: The project was carried out as a continuous quality improvement project. Four different specialities participated in the study with a nutrition team of both doctors, nurses, and a dietician, and included the following methods: (1) Pre-measurement: assessment of quality goals prior to study including the use of screening of nutritional risk (NRS-2002), whether a nutrition plan was made, and monitoring was documented in the records. (2) INTERVENTION: multidisciplinary meeting for the ward staff using a PC-based meeting system for detecting barriers in the department concerning nutrition, elaboration of an action plan and implementation of the plan. (3) Re-measurement: as in (1) based on information from records and patient interviews, and an evaluation based on focus group interview with the staff. Patients who gave informed consent to participate in the study (>14 years) were included consecutively. Mann-Whitney and Kruskal-Wallis test was used for ordinal data, and Pearson chi(2) test for nominative data. P values <0.05 were considered significant. The study was performed in accordance with the Research Ethics Committee. RESULTS: In this study 141/122 patients were included before/after the implementation period with a mean weight loss within the last 3 months of 6.2 and 5.2 kg, respectively. Before the study we found that BMI was not measured. More than half of the patients had a weight loss within the last 3 months, and 40% had a weight loss during hospitalization, and this was not documented in the records. About 75% had a food intake less than normal within the last week, and nearly one-third were at a severe nutritional risk, and only 33% of these had a nutrition plan, and 18% a plan for monitoring. Barriers concerning nutrition included low priority, no focus, no routine or established procedures, and insufficient knowledge, lack of quality and choice of menus, and lack of support from general manager of the hospital. The staff introduced individually targeted procedures including assigning of responsibility, a nutrition record, electronic calculator of energy intake, upgrading of the dieticians and special diets, communication, and educational programs. A great consistency existed between barriers for targeted nutrition effort and ideas for improvement of the quality goals between the different departments. Quality assessment after study showed an overall significant improvement of the selected quality goals. CONCLUSION: The introduction of a new method for implementation of nutritional therapy according to ESPEN screening guidelines seems to improve nutritional therapy in hospitals. The method included assessment of quality goals, identification of barriers and individual targeted plans for each department followed by an evaluation process. The model has to be refined further with relevant clinical endpoints.

Effect of cyclical intravenous clodronate therapy on bone mineral density and markers of bone turnover in patients receiving home parenteral nutrition.

BACKGROUND: Patients receiving home parenteral nutrition (HPN) because of intestinal failure are at high risk of developing osteoporosis. OBJECTIVE: We studied the effect of the bisphosphonate clodronate on bone mineral density (BMD) and markers of bone turnover in HPN patients. DESIGN: A 12-mo, double-blind, randomized, placebo-controlled trial was conducted to study the effect of 1500 mg clodronate, given intravenously every 3 mo for 1 y, in 20 HPN patients with a bone mass T score of the hip or lumbar spine of less than -1. The main outcome measure was the difference in the mean percentage change in the BMD of the lumbar spine measured by dual-energy X-ray absorptiometry. Secondary outcome measures included changes in the BMD of the hip, forearm, and total body and biochemical markers of bone turnover, ie, serum osteocalcin, urinary pyridinoline, and urinary deoxypyridinoline. RESULTS: The mean (+/-SEM) BMD of the lumbar spine increased by 0.8 +/- 2.0% in the clodronate group and decreased by 1.6 +/- 2.0% in the placebo group (P = 0.43). At all secondary skeletal sites (ie, hip, total body, and distal forearm), we observed no changes or small increases in the BMD of the clodronate group and decreases in the BMD of the placebo group. In the clodronate group, biochemical markers of bone resorption decreased significantly (P < 0.05). CONCLUSIONS: Clodronate significantly inhibits bone resorption as assessed by changes in biochemical markers of bone turnover. Although the mean BMD increased in the clodronate group, cyclic clodronate therapy failed to increase spinal BMD significantly at 12 mo.