Non-interventional, 5-year retrospective data of home parenteral nutrition in patients with benign chronic intestinal failure: Analysis of an Italian nurse registry (SERECARE II).

OBJECTIVE: This study is an assessment of home parenteral nutrition service performance and safety and efficacy outcomes in patients with benign chronic intestinal failure. METHODS: This is a retrospective, non-interventional, and multicenter study. Data were collected by trained nurses and recorded in a dedicated registry (SERECARE). RESULTS: From January 1, 2013 to June 30, 2018, data from a total of 683 patients with benign chronic intestinal failure were entered in the registry. Patients included 208 pediatric (53.8% male; median age = 4.0 y) and 475 adult (47.6% male; median age = 59.0 y) participants. On average, patients were visited 5.4 ± 4.5 times and received 1.4 ± 0.8 training sessions. Retraining was not common and mostly due to change of therapy or change of caregiver. Of 939 complications, 40.9% were related to the central venous catheter and were mostly infectious (n = 182) and mechanical (n = 187). The rate of infectious and mechanical complications per 1000 catheter days decreased over 5 y (0.30-0.15 and 0.33 -0.19, respectively). The rate of complications per 1000 catheter days and the mean complications per patient were higher in pediatric than in adult patients. The hospitalization rate was 1.01 per patient throughout the study period. These data were similar to those registered in a previous study period (2002-2011) (n = 1.53 per patient). Changes over time in the efficacy variables were mostly small and non-significant. CONCLUSIONS: This study confirms the importance of setting up and maintaining structured registries to monitor and improve home parenteral nutrition care. Safety outcomes have improved over the years, most likely due to the underlying efficient nursing service.

Intestinal iatrogenic hyperadaptation in patients with short bowel syndrome and Crohn's disease: Is this an indication for mandatory lifelong injections of teduglutide?

Short bowel syndrome with chronic intestinal failure (SBS-CIF) is a rare disease leading to a markedly decreased absorption of fluids and nutrients. Intestinal adaptation in patients with SBS-CIF who are treated with home parenteral nutrition is a natural repair process activated by increased secretions of glucagon-like peptide-2, inducing intestinal trophism, nutrient transport, and lowering gastrointestinal motility. Teduglutide (TED), a glucagon-like peptide-2 analog, offers a new, effective therapeutic alternative to boost intestinal adaptation. There is still no consensus regarding the question of whether intestinal adaptation is permanent or a transient, drug-dependent process requiring lifelong injections of TED. Here we report the clinical cases of two female patients with SBS-CIF secondary to Crohn's disease, who had received TED for 36 and 41 mo. In both patients, TED was discontinued for 5 d but needed to be resumed after an additional 5 d. In patient 1, the discontinuation of TED was accidental (the patient inadvertently injected frozen TED vials); whereas in patient 2, the suspension was at the patient's request. A rapid, significant (P < 0.0001) decline of intestinal function (diarrheal evacuations, fecal volume, food intake) was documented after the suspension of active TED in patient 1. After the resumption of active TED, the symptoms rapidly and significantly (P < 0.0001) improved. The same trend was observed in patient 2. Infective causes of diarrhea were ruled out in both patients. In conclusion, our experience shows that even after long-term treatment, the iatrogenic hyperadaptation process obtained with TED results is a temporary, drug-dependent process and vanishes with the suspension of therapy. These clinical cases suggest that in patients with SBS-CIF receiving TED, this treatment must be administered lifelong.

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.

Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis.

BACKGROUND: Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis. AIMS: To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response. METHODS: Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system. RESULTS: A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p < 0.001). Multivariate analysis revealed that a higher total Mayo score (p < 0.001, OR 1.5, 95% CI 1.2-1.8) and naïve status to anti-TNF-alpha (p = 0.015, OR 3.0, 95% CI 1.2-7.5) were predictive of a favorable response. Seventy-seven (39.3%) of the 130 responders maintained a response at month 12 of therapy. There were 17 adverse events, 28 patients needed hospitalization, and 15 patients underwent surgery. Self-administration of the drug was appreciated by most patients. CONCLUSIONS: The efficacy and safety of golimumab in daily clinical practice were confirmed for the short- and long-term treatment of patients with active ulcerative colitis. Patients naïve to the anti-TNF-alpha monoclonal antibody and those with a higher total Mayo score were more likely to respond to golimumab.

Non-interventional, retrospective data of long-term home parenteral nutrition in patients with benign diseases: Analysis of a nurse register (SERECARE).

OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of home parenteral nutrition (HPN) service in patients with benign chronic intestinal failure (CIF). METHODS: This was a 10-y retrospective, non-interventional, multicenter study conducted with adult and pediatric patients with CIF who received HPN service. We analyzed data prospectively collected from a dedicated register by HPN nurses. RESULTS: From January 2002 to December 2011 a total of 794 patients (49.7% male, median age 1 y for children and 57 y for adults) were included in the analysis. Over the 10-y period, 723 central venous catheter (CVC) complications occurred, of which 394 were infectious (54.5%), 297 were mechanical (41.1%), and 32 (3.3%) were defined as CVC-related thrombosis. The complication rate was higher in children (1.11 per patient) than in adults (0.70 per patient). During the observation period, the rates of both infectious and mechanical complications showed a global declining trend and ∼75% of patients had neither infectious nor mechanical CVC complications. HPN efficacy was evaluated in 301 patients with a minimum follow-up of 36 mo. Body mass index and Karnofsky score showed that the median growth significantly increased (P < 0.001) over baseline for adults and pediatric patients in the 0 to 2 age range. CONCLUSIONS: The use of a structured register has proved to be a key strategy for monitoring the outcomes of long-term treatment, improving time efficiency, and preventing potential malpractice. To our knowledge, this is the largest survey ever documented; the results were consistent despite the heterogeneity of the centers because of duly applied standard rules and protocols.

Undernutrition, risk of malnutrition and obesity in gastroenterological patients: A multicenter study.

AIM: To investigate the prevalence of undernutrition, risk of malnutrition and obesity in the Italian gastroenterological population. METHODS: The Italian Hospital Gastroenterology Association conducted an observational, cross-sectional multicenter study. Weight, weight loss, and body mass index were evaluated. Undernutrition was defined as unintentional weight loss > 10% in the last three-six months. Values of Malnutrition Universal Screening Tool (MUST) > 2, NRS-2002 > 3, and Mini Nutritional Assessment (MNA) from 17 to 25 identified risk of malnutrition in outpatients, inpatients and elderly patients, respectively. A body mass index ≥ 30 indicated obesity. Gastrointestinal pathologies were categorized into acute, chronic and neoplastic diseases. RESULTS: A total of 513 patients participated in the study. The prevalence of undernutrition was 4.6% in outpatients and 19.6% in inpatients. Moreover, undernutrition was present in 4.3% of the gastrointestinal patients with chronic disease, 11.0% of those with acute disease, and 17.6% of those with cancer. The risk of malnutrition increased progressively and significantly in chronic, acute and neoplastic gastrointestinal diseases in inpatients and the elderly population. Logistical regression analysis confirmed that cancer was a risk factor for undernutrition (OR = 2.7; 95%CI: 1.2-6.44, P = 0.02). Obesity and overweight were more frequent in outpatients. CONCLUSION: More than 63% of outpatients and 80% of inpatients in gastroenterological centers suffered from significant changes in body composition and required specific nutritional competence and treatment.

Clinical implications of mucosal healing in the management of patients with inflammatory bowel disease.

The natural history of Crohn's Disease and ulcerative colitis is characterized by repeated episodes of inflammation and ulceration of the bowel. This results in complications implying a worse quality of life and significant healthcare costs, due to hospitalization, surgery and an escalation of therapy. The main goal of the therapy in inflammatory bowel disease is to achieve and maintain disease remission, with an improved health-related quality of life, less hospitalization, and less surgery. The concept of remission has changed in the recent years. In fact the concept of clinical remission, where only the patients' symptoms are in remission, has been replaced by the new concept of deep remission. This implies not only sustained clinical remission but also complete mucosal healing, with the normalization of serological activity indexes. Mucosal healing, rarely achieved with traditional drugs, can now be achieved and maintained by means of biological drugs. Current evidence suggests that the achievement of mucosal healing might significantly change the natural course of inflammatory bowel diseases and should represent an objective end point of future therapeutic trials, particularly for colonic diseases.

Catheter-related complications in long-term home parenteral nutrition patients with chronic intestinal failure.

BACKGROUND: Home Parenteral Nutrition is a therapeutic option to improve quality of life in chronic intestinal failure. AIMS: To describe frequency of complications both in cancer and noncancer patients. METHODS: This study was performed on 270 adult patients (52% with cancer, 48% without cancer) followed for a total of 371 years of treatment. Mean duration of therapy was 191±181 for cancer and 830±1168 days/patient for noncancer. The treatment was administered by a competent, dedicated provider. Patients received our prescribed "all-in-one admixtures" at their homes. RESULTS: Catheter-related complications/1000-days-catheter was 1.40; mechanical complications were comparable in cancer (0.82) and noncancer (0.91) patients while a statistically significant difference was observed between cancer (0.71) and noncancer (0.46) patients for sepsis. Bacterial infections were more frequent in noncancer, mycotic infections primarily affected cancer patients. In our experience 49% of the patients were readmitted, with a low incidence rate of 0.89/1000 days-catheter. The incidence of hepatobiliary complications in our population was 65%. The degree of liver damage was related to short bowel syndrome and to length of treatment. CONCLUSIONS: This study indicated that cancer patients are more vulnerable to CVC-related infections during Home Parenteral Nutrition and that a safer Home Parenteral Nutrition protocol should be adopted in order to contain CVC-related complications.

Malnutrition and impaired muscle strength in patients with Crohn's disease and ulcerative colitis in remission.

OBJECTIVE: This prospective, controlled, and multicentric study evaluated nutritional status, body composition, muscle strength, and quality of life in patients with inflammatory bowel disease in clinical remission. In addition, possible effects of gender, malnutrition, inflammation, and previous prednisolone therapy were investigated. METHODS: Nutritional status (subjective global assessment [SGA], body mass index, albumin, trace elements), body composition (bioelectrical impedance analysis, anthropometry), handgrip strength, and quality of life were assessed in 94 patients with Crohn's disease (CD; 61 female and 33 male, Crohn's Disease Activity Index 71 +/- 47), 50 patients with ulcerative colitis (UC; 33 female and 17 male, Ulcerative Colitis Activity Index 3.1 +/- 1.5), and 61 healthy control subjects (41 female and 20 male) from centers in Berlin, Vienna, and Bari. For further analysis of body composition, 47 well-nourished patients with inflammatory bowel disease were pair-matched by body mass index, sex, and age to healthy controls. Data are presented as median (25th-75th percentile). RESULTS: Most patients with inflammatory bowel disease (74%) were well nourished according to the SGA, body mass index, and serum albumin. However, body composition analysis demonstrated a decrease in body cell mass (BCM) in patients with CD (23.1 kg, 20.8-28.7, P = 0.021) and UC (22.6 kg, 21.0-28.0, P = 0.041) compared with controls (25.0 kg, 22.0-32.5). Handgrip strength correlated with BCM (r = 0.703, P = 0.001) and was decreased in patients with CD (32.8 kg, 26.0-41.1, P = 0.005) and UC (31.0 kg, 27.3-37.8, P = 0.001) compared with controls (36.0 kg, 31.0-52.0). The alterations were seen even in patients classified as well nourished. BCM was lower in patients with moderately increased serum C-reactive protein levels compared with patients with normal levels. CONCLUSION: In CD and UC, selected micronutrient deficits and loss of BCM and muscle strength are frequent in remission and cannot be detected by standard malnutrition screening.

Cholestasis induced by total parenteral nutrition.

Parenteral nutrition is a life-saving treatment for patients who have acute and chronic intestinal failure. Severe cholestasis induced by total parental nutrition (TPN-IC) is characterized by bile duct regeneration, portal inflammation, and fibrosis. Its progression could be very rapid, and in some patients liver cirrhosis may develop in few months. This article describes the definition, incidence, hepatic changes, histopathologic findings, risk factors, pathogenesis, and clinical implications of TPN-IC. The goal is to improve hospital and home management, quality of life, and prognosis of patients requiring parenteral nutrition.