Parenteral Nutrition Volume Research Articles

Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry.

The Short Bowel Syndrome (SBS) Registry (NCT01990040) is a multinational real-world study evaluating the long-term safety of teduglutide in patients with SBS and intestinal failure (SBS-IF) in routine clinical practice. This paper describes the study methodology and baseline characteristics of adult patients who have (ever-treated) or have never (never-treated) received teduglutide. A total of 1411 adult patients (679 ever-treated; 732 never-treated) were enrolled at 124 sites across 17 countries. The mean (standard deviation [SD]) age at enrollment was 55.4 (15.46) years, and 60.2% of patients were women. Crohn's disease was the most common cause of major intestinal resection in both ever-treated (34.1%) and never-treated patients (20.4%). A similar proportion of ever-treated and never-treated patients had a prior history of colorectal polyps (2.7% vs. 3.6%), whereas proportionally fewer ever-treated patients reported a history of colorectal cancer (1.8% vs. 6.2%) or any malignancy (17.7% vs. 30.0%) than never-treated patients. Never-treated patients received a numerically greater mean (SD) volume of parenteral nutrition and/or intravenous fluids than ever-treated patients (12.4 [8.02] vs. 10.1 [6.64] L/week). Ever-treated patients received a mean teduglutide dosage of 0.05 mg/kg/day. This is the first report of patient baseline characteristics from the SBS Registry, and the largest cohort of patients with SBS-IF to date. Overall, ever-treated and never-treated patients had similar baseline characteristics. Differences between treatment groups may reflect variations in patient selection and degree of monitoring.

Nutritional Outcomes of Bowel Lengthening Procedure in Patients with Short Bowel Syndrome.

Although parenteral nutrition (PN) significantly improves mortality rates in pediatric short bowel syndrome (SBS), long-term PN has many possible complications and impacts quality of life. Bowel lengthening procedures (BLPs) increase the contact surface of food and the intestinal mucosa and enable the better absorption of nutrients and liquids, possibly leading to a PN decrease. We retrospectively reviewed the data of patients with short bowel syndrome who underwent BLPs in the period from January 2016 to January 2022. Overall, eight patients, four male, five born prematurely, underwent BLPs. There was a significant decrease in the percentage of total caloric intake provided via PN and PN volume after the BLPs. The more evident results were seen 6 months after the procedure and at the last follow-up, which was, on average, 31 months after the procedure. Two patients were weaned off PN after their BLPs. Patients remained well nourished during the follow-up. The BLP led to a significant decrease in PN needs and an increase in the food intake; however, significant changes happened more than 6 months after the procedure.

Early use of teduglutide in paediatric patients with intestinal failure is associated with a greater response rate: a multicenter study.

Teduglutide is a glucagon-like-peptide-2 analogue that reduces the need for parenteral support in patients with short bowel syndrome (SBS). Nevertheless, data about long-term therapy with teduglutide in children are still scarce. Our objective was to describe the real-life experience with teduglutide in children with SBS over the last 5years in Spain. This was a national multicentre and prospective study of paediatric patients with intestinal failure (IF) treated with teduglutide for at least 3months. The data included demographic characteristics, medical background, anthropometric data, laboratory assessments, adverse events, and parenteral nutrition (PN) requirements. Treatment response was defined as a > 20% reduction in the PN requirement. The data were collected from the Research Electronic Data Capture (REDCap) database. Thirty-one patients from seven centres were included; the median age at the beginning of the treatment was 2.3 (interquartile range (IQR) 1.4-4.4) years; and 65% of the patients were males. The most frequent cause of IF was SBS (94%). The most common cause of SBS was necrotizing enterocolitis (35%). The median residual bowel length was 29 (IQR 12-40) cm. The median duration of teduglutide therapy was 19 (IQR 12-36) months, with 23 patients (74%) treated for > 1year and 9 treated for > 3years. The response to treatment was analysed in 30 patients. Twenty-four patients (80%) had a reduction in their weekly PN energy > 20% and 23 patients (77%) had a reduction in their weekly PN volume > 20%. Among the responders, 9 patients (29%) were weaned off PN, with a median treatment duration of 6 (IQR 4.5-22) months. The only statistically significant finding demonstrated an association between a > 20% reduction in the weekly PN volume and a younger age at the start of treatment (p = 0.028). Conclusions: Teduglutide seems to be an effective and safe treatment for paediatric patients with IF. Some patients require a prolonged duration of treatment to achieve enteral autonomy. Starting treatment with teduglutide at a young age is associated with a higher response rate. What is Known: • Glucagon-like peptide-2 (GLP-2) plays a crucial role in the regulation of intestinal adaptation in short bowel syndrome (SBS). Teduglutide is a GLP-2 analog that reduces the need for parenteral support in patients with SBS. •Data about long-term therapy with teduglutide in children in real life are still scarce. What is New: • Most pediatric patients with SBS respond in a satisfactory manner to teduglutide treatment. The occurrence of long-term adverse effects is exceptional. • Starting treatment with the drug at a young age is associated with a greater response rate.

Parenteral Nutrition, Sepsis, Acute Heart Failure and Hepatotoxic Drugs Are Related to Liver Test Disturbances in Critically Ill Patients.

Parenteral nutrition (PN) is often associated with liver dysfunction in the ICU, although other factors such as sepsis, acute heart failure (AHF), and hepatotoxic drugs can be equally present. The relative impact of PN on liver dysfunction in critically ill patients is largely unknown. We recorded the presence of pre-existing liver disturbances, AHF, sepsis, daily PN volume, and commonly used hepatotoxic drugs in adult ICU patients, together with daily aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), alkalic phosphatase (AP), total bilirubin (TB), and INR values in patients with three or more PN treatment days. A linear mixed-effects model was used to assess the relative contribution of each liver parameter. Nutritional adequacy was defined as intake/needs. We included 224 ICU patients with PN treatment lasting more than 3 days between 1 January 2017 and 31 December 2019. For AST, pre-existing liver disturbances (+180% ± 11%) and the presence of AHF (+75% ± 14%) were the main predictors of deterioration, whereas PN volume caused only a limited increase of 14% ± 1%/L. Similar results were observed for ALT. GGT, INR, and TB are mainly influenced by the presence of sepsis/septic shock and pre-existing liver disturbances, with no impact of PN or hepatotoxic drugs. Carbohydrate intake exceeded recommendations, and protein and lipid intake were insufficient in this study cohort. Liver test disturbances in ICU patients on PN are multifactorial, with sepsis and AHF having the highest influence, with only limited impact from PN and hepatotoxic drugs. Feeding adequacy can be improved.

Long-term results of teduglutide treatment for chronic intestinal failure - Insights from a national, multi-centric patient home-care service program.

Teduglutide is a Glucagon-like peptide-2 (GLP-2) agonist indicated for the treatment of patients with parenteral support (PS) dependent short bowel syndrome (SBS) with chronic intestinal failure (cIF). Its application is accompanied by a structured nation-wide home-care service program in Germany. We investigated care characteristics and outcome parameters in a clinical real-world observational setting. Data generated within a therapy-accompanying home-care service program for adult SBS-cIF patients were analyzed retrospectively for patients treated up to 1 year (data cut: April 2020). In total, 52 teduglutide-treated patients were included by 6 German cIF centers. At teduglutide administration start, 49/52 patients were on PS, 3 of them without macronutrients. The majority of patients received individualized parenteral nutrition (PN) (n=32/46), while 13/46 were on commercial premixed bags. PS application was done by patients themselves (37%), home-care nurses (19%), relatives (8%) or by a combination of those (16%). In patients with PS dependency at baseline and available follow-up data (n=40-44), teduglutide treatment resulted in significantly reduced PN days, caloric needs, infusion time, and infusion volume after 6 and 12 months. After 1 year, reduction of infusion time was positively correlated with a reduction of PN calories and volume; 30 patients (68%) were responders (PS-volume reduction ≥20%), and 6 patients (14%) were completely weaned off PS. Sleep disturbances per night were significantly reduced after 3 months of treatment and stool characteristics improved in consistency and significantly in frequency, while meal frequency remained stable. Teduglutide treatment associated reduction in PS volume and calories was accompanied by reduced infusion days, infusion times, sleep disturbances, stable oral intake surrogates, and improved stool characteristics, all of these potential parameters for improving quality of life. Furthermore, analyzed care characteristics reflect SBS-cIF treatment as a complex, resource-intensive and demanding task for both, healthcare system and patients.

Changes in Parenteral Nutrition Requirements and BMI in Patients with Parenteral Nutrition-Dependent Short Bowel Syndrome after Stopping Teduglutide-9 Years of Follow-Up.

Teduglutide (TED) is widely used in patients with short-bowel-syndrome-associated intestinal failure (SBS-IF) to enhance intestinal adaptation and reduce the need for parenteral support (PS). There are limited data on the effects of discontinuing TED. In this study, we describe the changes in parenteral nutrition (PN) requirements and body mass index (BMI) in a 9-year follow-up of patients receiving home parenteral nutrition after discontinuation of the TED treatment. We performed a retrospective analysis of changes in weekly PN orders and BMI in all patients with PN-dependent SBS from two Polish home parenteral nutrition (HPN) centers who received teduglutide between 2009 and 2013 and still required HPN 9 years after discontinuation of the TED treatment. Data included in the analysis were collected prospectively at mandatory visits to the HPN centers at 12, 24, 60, 84, and 108 months after drug discontinuation and compared with values before and after TED treatment. Weekly PN volume values varied significantly between all of the above time points from baseline to 9 years after TED discontinuation (χ2 = 34.860, p < 0.001). After an initial increase within the first year after treatment discontinuation (not statistically significant), the PN volume requirements remained stable for 4 years and increased 5–9 years after treatment discontinuation. The rate of patients requiring an increase in PN volume was 84.62% at 60 and 84 months and 92.30% at 108 months. At 9 years after cessation of the TED treatment, 53.85% of the study group required a 21.21% increase in PN volume compared with values before treatment. The need for PN volume in patients with PN-dependent SBS who discontinued the TED treatment increased within the first year and 4–5 years after treatment cessation, and in some cases might even exceed pretreatment values after 9 years.

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Highlights from the literature

This prospective observational study evaluated the role of teduglutide, a semisynthetic analogue of glucagon-like peptide-2 (sGLP-2), in reducing the need for parenteral nutrition in adults with short bowel syndrome. One...

Postsurgical Intestinal Rehabilitation Using Semisynthetic Glucagon‐Like Peptide‐2 Analogue (sGLP‐2) at a Referral Center: Can Patients Achieve Parenteral Nutrition and sGLP‐2 Independency?

Teduglutide, a semisynthetic analogue of glucagon-like peptide-2 (sGLP-2), increases intestinal absorption of fluids and nutrients, reducing the need for parenteral nutrition (PN). This report aims to describe our experience with sGLP-2 in a cohort of adult patients with short-bowel syndrome. This is a prospective observational study on adult patients initially evaluated in our specialized intestinal rehabilitation program that received sGLP-2 from June 2014 to March 2020. Autologous gastrointestinal reconstruction surgery (AGIRS) was performed in 108 patients; 68.5% (74 of 108) achieved intestinal sufficiency with standard medical therapy. Seventeen patients were treated with sGLP-2; 66.5% (8 of 12) received treatment for a mean time of 25.8 weeks (3.4-54.0) and could suspend PN. One patient reinitiated treatment due to renal lithiasis and acute renal failure. Currently, 7 of 12 patients (53.8%) continue without PN for a mean time of 165.6 weeks. Volume, energy, and days of PN were reduced in all patients. No serious adverse events were registered. Four of 7 patients (57.1%) who discontinued PN could also discontinue sGLP-2. Therefore, the use of sGLP-2 increased the overall success rate of PN independency after AGIRS to 76% (82 of 108). This study confirmed that sGLP-2 should be considered as part of the standard therapy for postsurgical medical rehabilitation treatment in patients with chronic intestinal failure. We add to the current knowledge that some patients can discontinue both PN and sGLP-2 in the long term, achieving complete recovery of their quality of life.

Nephrocalcinosis and Renal Dysfunction in Pediatric Intestinal Failure

Outcomes of pediatric intestinal failure (PIF) have improved recently, with other comorbidities, such as increased echogenicity/nephrocalcinosis on ultrasound (US) in long-term survivors now evident. We evaluated the significance of nephrocalcinosis over time in PIF and its impact on renal function. Retrospective analysis on a cohort of PIF patients was performed. Presence of nephrocalcinosis and/or increased renal echogenicity (identified on US), estimated glomerular filtration rate (eGFR; ml · min · 1.73 m2), renal tubular function, PN volume (ml · kg · day) and PN exposure time (hours/day) were reviewed annually over a follow-up period of 2 years. Outcomes in the nephrocalcinosis versus normal US groups were compared. Forty patients (28 boys, median age 2.7 years) were followed for 2 years. Fifteen (38%) had either increased echogenicity or nephrocalcinosis (group 1) at initial US. US were normal in the remaining 25 (62%) on initial assessment (group 2). eGFR did not differ between group 1 and group 2 at baseline (118 vs 133, P = 0.51) and year 2 (130 vs 131, P = 1.00). The percentage of patients with abnormal markers of tubular function was similar in both groups at year 2 (high urine calcium: creatinine 33 versus 30, P = 0.83; high urine calcium: citrate 39 versus 42, P = 0.87; low urine citrate: creatinine 15 versus 17, P = 1.00; high urine oxalate: creatinine 39 versus 25, P = 0.77). A large proportion of PIF patients with a history of parenteral nutrition (PN) exposure have nephrocalcinosis and/or increased echogenicity on US. Over a 2-year follow-up period, however, these abnormalities had no impact on eGFR or renal tubular function.

Gastrointestinal Tract Reconstruction in Adults with Ultra-Short Bowel Syndrome: Surgical and Nutritional Outcomes

BackgroundHistorically, adults with ultra short bowel syndrome (USBS) have been considered candidates for lifetime parenteral nutrition (PN) or are referred for visceral transplantation. We examined the surgical and nutritional outcomes of adult patients with USBS managed at a single intestinal rehabilitation center. MethodsWe retrospectively reviewed data on 588 adult patients referred to our center between January 2013 and December 2018. USBS was defined as residual small bowel (SB) length ≤ 50 cm. ResultsForty-five patients (7.6%) with a mean age of 46.7 years (range 17-78) were identified. Indications for enterectomy included mesenteric ischemia (n=17) and internal hernias (n=6), followed by large intraabdominal fibroids, trauma, and allograft enterectomies, with five cases each. Median SB length was 18.0 cm; 20 patients (44.4%) had their entire SB resected. Thirteen patients had an intact colon, of which nine had preservation of the ileocecal valve. Patients who underwent autologous reconstruction of their gastrointestinal (GI) tract required a lower total PN volume (29.0 ± 7.6 vs. 40.8 ± 13.2 ml/Kg/day, p=0.002) and presented better short- and long- term survival (p=0.005). Patients with no gut had higher mortality (p=0.036). Hormonal therapy with the glucagon-like peptide-2 analog teduglutide was used in nine patients (20%) five of whom were weaned off TPN. Excluding patients with no gut (n=20), discontinuation of total PN rate for patients with an end ostomy or tube decompression (n= 6), jejunocolostomy (n= 10), and jejunoileostomy (n=9) were 0%, 40%, and 77.7%, respectively. Eleven patients (44%) with some residual small intestine achieved nutritional autonomy in an average of 20 months after GI reconstruction. Fifteen patients were listed for transplantation (33.3%). Seven patients underwent isolated SB transplantation and achieved nutritional autonomy in an average of three months after transplantation. One-year patient and graft survival were 100%. After a 37-month median follow-up period, 36 of 42 patients followed by our center were still alive (85.7%). ConclusionNutritional autonomy can be achieved in a significant number of patients with USBS in specialized centers with surgical and/or hormonal therapy. The presence of an intact colon and ileocecal valve can significantly increase the adaptation rate. Moreover, restoration of GI tract continuity has a positive impact on medical management and survival.

Neonates treated with individualized parenteral nutrition who are candidates to receive standardized parenteral nutrition

Objetive: to quantify the number of neonates treated with individualized parenteral nutrition (IPN) who were candidates to receive standardized parenteral nutrition (SPN), and to calculate their treatment duration. Material and methods: this was a prospective, observational, descriptive cohort study. Inclusion criteria were: neonates with indication of parenteral nutrition (PN) and individualized prescription. Exclusion criteria included: patients who had not started diuresis, with specific nutritional needs, altered acid-base balance, and/or contraindication to receive SPN. Included variables were patient-related (gender, weight, weeks of gestation, and days of life) and treatment-related regarding IPN composition. Setting the volume of PN as the conversion criterion, theoretical contributions were calculated with the SPN. The criterion for a patient to be a candidate to receive SPN was that all the theoretical contributions calculated were within the reference requirements range. Results: a total of 33 neonates (9 women) received IPN with 94 prescriptions. The median weight of the patients included in the study was 2.14 (IQR, 0.9) kg, and they were born at 35 (IQR, 3) weeks of gestation. PN began between 0 and 4 days of life. In all, 71 % (22/31) of the patients in 54.1 % of their (46/85) prescriptions were candidates to receive SPN via central administration for 1 to 8 days, whereas no patient was candidate to receive SPN via peripheral administration. Conclusions: in our center, 71 % of neonates treated with central administration of IPN are candidates to receive SPN, thus promoting the normalization of nutritional support in this population.

250.6: Results of a Multicentric Retrolective Study of Teduglutide Treatment in Benign Short Bowel Syndrome in Germany

Introduction: Teduglutide (TED) is a medical treatment for intestinal functional rehabilitation of short bowel syndrome (SBS) patients with chronic intestinal failure (cIF). Its application and effectivity is routinely monitored in a structured home care service program by a multicentric approach in Germany. From these prospectively documented data, a retrolective data base was generated in order to study treatment characteristics and outcome parameters in a clinical routine setting of TED-treated cIF-patients. Methods: For the present interim analysis, prospectively collected clinical data until December 2018 were retrolectively analyzed. Statistical analyses were performed with SPSS using repeated measures ANOVA and Friedman-Test with subsequent Bonferroni-adjusted post-hoc analyses for TED treatment characteristics up to one year. Results: So far, 29 patients (f:17 / m:12, median age 52 years) were included in this interim analysis. Causes of SBS included vascular (n=12) and inflammatory diseases (n=6), ileus (n=4), injury (n=4) and others (n=3). Median time on parenteral support (PS) before TED was 30 months. At TED start, 72% of patients (21/29) received individually compounded parenteral nutrition (PN); the remaining 28% received standardized PN. PS was administered by patients themselves (n=15), by relatives (n=3), by nurses (n=8) or others (n=3). TED treatment resulted in a significant reduction in PN calories and volume requirements as well as reduced infusion days per week and shortened infusion times (see Table 1). The reduction of infusion time was positively correlated with the reduction of PN volume (p<0.001; r=0.75) and calories (p=0.003; r=0.59) after one year of TED treatment. After one year, 22 of 29 (76%) patients were considered responders to TED treatment (with a minimum of 20% i.v.-volume reduction). Conclusion: In this multicentric real-world analysis of severely PS-dependent SBS/cIF-patients, TED displays effectivity with regards to improvement of intestinal absorptive function as indicated by significantly reduced weekly i.v.-volume and calorie requirements. In addition, the findings demonstrate a reduction of effective infusion days and times, which both importantly affect patients’ wellbeing. These data indicate the effectivity of TED treatment in a national routine treatment setting in concordance with clinical trial data and guideline recommendations.

Early Continuous Renal Replacement Therapy Improves Nutrition Delivery in Neonates During Extracorporeal Life Support

Optimizing nutrition in neonatal patients as soon as possible after extracorporeal life support (ECLS) initiation is imperative as malnutrition can worsen both short- and long-term outcomes. Fluid restriction, used to manage the fluid overload that commonly complicates neonatal ECLS, severely impairs nutrition delivery. Continuous renal replacement therapy (CRRT) can be used to help manage fluid overload. We hypothesize that early CRRT utilization ameliorates the need for fluid restriction and allows providers to prescribe higher parenteral nutrition (PN) volumes leading to better nutrition delivery. The design of the study was a retrospective chart review, and the setting was a single, level III neonatal intensive care unit. Neonatal patients (n=42) treated with ECLS between January 1, 2008, and December 31,2013. Comparisons were made between 2 groups: neonates who received ECLS without early CRRT initiation (group 1; n=23) and with early CRRT initiation (group 2; n=19). The main outcome measures were goal total fluid intake, prescribed PN volume, protein, glucose infusion rate, intralipid, and kilocalories. Infants who received early CRRT were prescribed higher mean total fluid intake goals (group 1: 99mL/kg/day vs. group 2: 119mL/kg/day, P<.001) and higher mean volumes of PN (group 1: 61mL/kg/day vs. group 2: 81mL/kg/day, P<.001) over the first 72hours of ECLS compared with infants who did not receive early CRRT. Early CRRT receivers also were prescribed greater mean amounts of protein during the first 72hours of ECLS (group 1: 2.7g/kg/day vs. group 2: 3g/kg/day, P=0.03). There were no significant changes noted in prescribed glucose infusion rates, intralipid, or total kilocalories. Institution of early CRRT in neonates on ECLS allows for administration of greater volumes of PN with improved protein delivery. This study characterizes one benefit of early CRRT initiation in neonates on ECLS and suggests these patients could experience improved nutritional outcomes.

Iodine Content of Enteral and Parenteral Nutrition Solutions

Iodine is essential for thyroid hormone synthesis, and iodine deficiency may result in thyroid disorders including goiter and hypothyroidism. Patients on long-term enteral nutrition (EN) or parenteral nutrition (PN) may be at risk for micronutrient deficiencies. The recommended daily allowance for iodine intake is 150 μg for nonpregnant adults. However, there is no current consensus among scientific societies regarding the quantity of iodine to be added in adult EN and PN formulations. The objective of this study was to determine the iodine content of U.S. adult enteral and parenteral nutrition solutions. This study also aimed to determine whether adult patients in the United States who are receiving long-term artificial nutrition may be at risk for iodine deficiency. Ten enteral nutrition solutions and 4 parenteral nutrition solutions were evaluated. The iodine contents of these solutions were measured spectrophotometrically and compared to the labeled contents. Measured and labeled EN iodine contents were similar (range 131-176 μg/L and 106-160 μg/L, respectively). In contrast, PN formulas were found to contain small, unlabeled amounts of iodine, averaging 27 μg/L. Typical fluid requirements are 30 to 40 mL/kg/day for adults receiving either total EN (TEN) or total PN (TPN). Adults on long-term TEN likely consume enough servings to meet their daily iodine requirements. However, patients on long-term TPN would require on average 5.6 L PN/day to meet the recommended daily allowance of iodine. This volume of PN is far in excess of typical consumption. Thus, U.S. patients requiring long-term TPN may be at risk for iodine deficiency. EN = enteral nutrition; PN = parenteral nutrition; TEN = total enteral nutrition; TPN = total parenteral nutrition; UIC = urinary iodine concentration.

Predictors of Response to Teduglutide Among Patients with Parenteral Nutrition–Dependent Short Bowel Syndrome

Introduction: The study aimed to identify factors associated with sustained parenteral nutrition (PN) volume reduction and early vs late responders among PN-dependent short bowel syndrome patients treated with teduglutide (TED). Methods: The study population was 43 patients receiving TED in a 24-week randomized placebo-controlled trial (STEPS: NCT00798967; EudraCT2008-006193-15) who could continue TED up to 24 months in the open-label extension (STEPS-2: NCT00930644; EudraCT2009-011679-65). Time to sustained PN volume reduction (i.e., PN volume reduction ≥20% at 2 consecutive visits) was calculated using Kaplan-Meier analysis. Multivariable Cox model was used to identify factors associated with sustained PN volume reduction. Among patients achieving sustained PN volume reduction, baseline characteristics were compared between early (PN volume reduction ≥20% at week 20 and 24) vs. late responders (sustained PN volume reduction at 2 consecutive visits after week 24). Results: The median time to sustained PN volume reduction was 4.2 months. Patients with stoma, compared to those without, were significantly more likely to achieve sustained PN volume reduction (hazard ratio [HR], 5.6; P = 0.01). Patients with an ileocecal valve, compared to those without (HR = 0.1; P = 0.03), and patients with major intestinal resection due to vascular disease, compared to those with Crohn’s disease (HR = 0.2; P = 0.02), were significantly less likely to achieve sustained PN volume reduction. Compared to late responders (n = 7), early responders (n = 27) were less likely to have colon-in-continuity (52% vs 100%; P = 0.02) and ileocecal valve (0% vs 29%; P < 0.01), and had smaller mean percentage of colon remaining (25% vs 57%; P = 0.02). The median time to sustained PN volume reduction was 3.7 months for early responders and 7.8 months for late responders. Conclusion: Presence of stoma and absence of ileocecal valve are good prognosis factors for achieving sustained PN volume reduction while vascular disease as cause of intestinal resection is a negative prognosis factor. Certain anatomical factors were significantly different between early and late responders. This research was funded by Shire Human Genetic Therapies, Inc., Lexington, MA, USA.

Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome

To determine safety and pharmacodynamics/efficacy of teduglutide in children with intestinal failure associated with short bowel syndrome (SBS-IF). This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds. Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5). Descriptive summary statistics were used. All patients experienced ≥1 treatment-emergent adverse event; most were mild or moderate. No serious teduglutide-related treatment-emergent adverse events occurred. Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide. In contrast, PN volume and calories changed by 0% and -6%, respectively, with 0.0125 mg/kg/d teduglutide and by 0% and -1% with SOC. Per patient diary data, EN volume increased by a median of 22%, 32%, and 40% in the 0.0125, 0.025, and 0.05 mg/kg/d cohorts, respectively, and by 11% with SOC. Four patients achieved independence from PN, 3 in the 0.05 mg/kg/d cohort and 1 in the 0.025 mg/kg/d cohort. Study limitations included its short-term, open-label design, and small sample size. Teduglutide was well tolerated in pediatric patients with SBS-IF. Teduglutide 0.025 or 0.05 mg/kg/d was associated with trends toward reductions in PN requirements and advancements in EN feeding in children with SBS-IF. ClinicalTrials.gov:NCT01952080; EudraCT: 2013-004588-30.

CAN THE '4 P'S OF PN' IMPROVE NEONATAL NUTRIENT INTAKE?

AimsELBW infants on NICU were found to have poor growth compared to network data. Previous audit work1 showed that the time from birth to PN did not meet unit guideline...

A multicenter cross­sectional survey on the use of parenteral nutrition in hospitalized patients in Beijing

Objective To investigate the use of parenteral nutrition in hospitalized patients and to examine the process of care of patients receiving parenteral nutrition (PN) in hospital, in light of EuropeanNutrition Daystudy, and to preliminarily explore the possible main risk factors for complications. Methods We recruited 314 adult hospitalized patients (≥18 years) requiring PN on a predetermined day(November 25, 2013)in 6 hospitals in Beijing and investigated their disease status, nutrition risk, the use of PN and venous infusion related complications using the European Nutrition Day survey questionnaire. Results Of the 314 patients, 311 completed the survey.In the 311 patients, the proportion of patients who received PN ofall-in-onemixed preparation was 76.2%(237/311), the proportion of patients receiving multibottle system was 23.8%(74/311); PN was administered via central vein in 56.8% (171/301) of the patients and via peripheral veins in 43.2%(130/301) of the patients. The mean duration of infusion was (12.5±5.1) hours. The ratio of glucose to fat was 0.84 and the ratio of non-protein to calories 531.1. The total energy provision was less than the recommended intake. 38.6% (120/311) of the patients reported that PN infusion would affect activity, and 33.4% (104/311) thought PN affected their sleep, and the incidence of infusion-related pain was 19.9%(62/311). Multivariate analysis result showed that the most important factors of infusion-related pain were intravenous route of PN (χ2=25.911, P=0.000) and total venous infusion volume (χ2=6.053, P=0.014). Conclusions The total energy provision of PN is generally inadequate in hospitalized patients in Beijing. The key factor for reducing transfusion-related pain and enhancing PN tolerance is to establish appropriate infusion route. Key words: Nutrition Day; Parenteral nutrition; Energy; Volume; Venous infusion related complications

Teduglutide: GLP-2 analog for short bowel syndrome

In late December, FDA approved teduglutide (Gattex—NPS) to treat short bowel syndrome in adult patients who need additional nutrition from I.V. parenteral nutrition. The drug is a glucagon-like peptide-2 (GLP-2) analog that improves intestinal absorption of fluids and nutrients, thereby reducing the frequency and volume of parenteral nutrition. Teduglutide is only the third drug approved to treat adults with short bowel syndrome receiving nutritional support.