Faculty Bibliography

PRECIS/CONCLUSIONS: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/OBJECTIVE: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.

Published epidemiologic data on the administration rates of enteral/parenteral home nutrition is very limited. The aim of this first nationwide study was to assess the availability of pediatric home enteral nutrition (HEN) services in Poland. The questionnaire was sent to all regional centers providing pediatric HEN services in Poland (n = 14). The analysis included the number of pediatric patients who received HEN in 2010, their demographic characteristics and geographical distribution. Furthermore, the distributions of indications and methods of enteral nutrition administration were analyzed, along with the reasons of withdrawal from the HEN program. The number and fraction of children receiving HEN increased in 2010, from 433 (11.34 per 1 million inhabitants) on January 1st to 525 (13.75) on December 31st. Marked differences were observed in geographical distribution of this parameter, from zero to up to 30 pediatric patients per 1 million inhabitants. Median age of patients was 6 years (range: 9 months-18 years). In most cases, HEN was prescribed due to neurological disorders (n = 337, 64.2%), and administered by means of gastrostomy (n = 450, 85.71%). This study revealed the dynamic development of pediatric HEN services in Poland but also documented their potential regional shortages.

BACKGROUND:The aim of this study was to analyse the composition of parenteral nutrition (PN) mixtures used in the ITU. METHODS:Restrospective analysis involved 2124 prescriptions for individual PN bags. They were administered over an 18-month period, to 160 ITU patients with the mean APACHE II score of 26 points (range: 5-61), calculated on admission. The mortality rate was 40%. Nutrition programs were prepared individually following the 2009 ESPEN guidelines. The prescription was modified according to the individual patient's clinical condition. One hundred and sixty prescriptions were analysed on the first day of PN (T1), 139 - on the second day (T2) and 1825 on the third and subsequent days (T3). RESULTS:The mean energy supplies were: 1381 kcal/day (range: 456-2612) on T1, 1467 kcal/day (range: 524-2860) on T2, and 1654 kcal/day (range: 390-2969) on T3. The mean supplies of amino acids, glucose and lipids were as follows: amino acids 68.3 g/day (range:20-120) on T1; 71.6 g/ day (range:27.5-125) on T2; 88.0 g/day (range:11-196) on T3; glucose 210.25 g/day (range: 120- 400) on T1; 218.34 g/day (range: 65-480) on T2; 278.5 g/day (range: 18-520) on T3; lipids 34.9 g/ day (range: 0-100) on T1; 38.7 g/day (range: 0-100) on T2; 52.66 g/day (range: 0-117) on T3. The percentages of non-protein energy from lipids were: 29.25 (0-73) on T1; 31.58 (range: 0-60) on T2; 33.5 (0-60) on T3. The following statistically significant differences were found: T2-T3- (p<0.05). CONCLUSIONS:The compositions of nutrition bags prepared for ITU patients were consistent with the ESPEN guidelines. The composition varied on different days of nutrition. The differences in the supply of nutrition components indirectly confirm the need for individual prescriptions for ITU patients.

BACKGROUND & AIMS/OBJECTIVE:Malnourished surgical patients are supposed to benefit from perioperative nutrition. It is unclear, however, whether enteral intervention really surpasses the parenteral one, and whether the modification of standard formula matters. The aim of the study was to evaluate the clinical value of the route and type of perioperative nutritional support. METHODS:A group of 167 malnourished patients (91 M, 76 F, mean age 61.4 years) operated between June 2001 and December 2008 was randomly assigned during postoperative period to four groups according to nutritional intervention: enteral and parenteral, standard or immunomodulating. All patients received parenteral nutrition before surgery for 14 days, which provided homogenous groups for the postoperative evaluation. The trial was designed to test the hypothesis that enteral nutrition and/or immunonutrition can reduce the incidence of postoperative complications. RESULTS:The incidence of individual complications was comparable among all four groups (p > 0.05). Infectious complications occurred in 23 of 84 patients with standard diets and in 20 of 83 patients receiving immunomodulatory formula (odds ratio 0.84; 95% CI 0.42 to 1.69). There were no significant differences in infectious complications' ratio in patients receiving enteral (24/84 patients) and parenteral formulas (19/83 patients). Neither immunomodulating formulas nor enteral feeding significantly affected the length of hospitalization, overall morbidity and mortality rates. CONCLUSIONS:Results demonstrated that postoperative nutritional intervention generates comparable results regardless of the route and formula used and that preoperative intervention is of the utmost importance. The study was registered in the Clinical Trials Database - number: NCT 00558155.

BACKGROUND & AIMS/OBJECTIVE: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.

BACKGROUND & AIM/OBJECTIVE:The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients, but many authors have questioned its value recently. The aim of the study was to assess the impact of enteral immunonutrition in postoperative period. METHODS:Between January 2003 and December 2009, 305 malnourished patients (123 F, 182 M, m. age 60.8) undergoing resection for pancreatic or gastric cancer, after preoperative 14 days of parenteral feeding, were randomized in double-blind manner to receive either postoperative immunomodulating enteral diet (IMEN) or standard oligopeptide diet (SEN). Outcome measures of the intend-to-treat analysis were: number and type of complications, length of hospitalization, mortality, and vital organ function. RESULTS:Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group (p = 0.006). Infectious complications were observed in 60 patients (39.2%) in SEN and 43 (28.3%) in IMEN group (p = 0.04). Differences were also observed in overall morbidity (47.1 vs 33.5%, p = 0.01) and mortality (5.9 vs 1.3%, p = 0.03), but the ratio of surgical complications, organ function, and treatment tolerance did not differ. CONCLUSIONS:The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients. The Clinical Trials Database registry number: NCT00576940.

BACKGROUND:The benefits of home enteral tube feeding (HETF) provided by nutrition support teams (NSTs) have been questioned recently, given the growing costs to the healthcare system. This study examined the effect of a specialized home enteral nutrition program on clinical outcome variables in HETF patients. METHODS:The observational study included 203 patients (103 women, 100 men; mean age 52.5 years) receiving HETF with homemade diets for at least 12 months before starting a specialized home nutrition program for another 12 months consisting of provision of commercial enteral formulas and the guidance of an NST. Both study periods were compared regarding the number of hospital admissions, length of hospital and intensive care unit (ICU) stay, and costs of hospitalization. RESULTS:A specialized HETF program significantly reduced the number of hospital admissions and the duration of hospital and ICU stays. The need for hospitalization and ICU admission was significantly reduced, with odds ratios of 0.083 (95% confidence interval, 0.051-0.133, P < .001) and 0.259 (95% confidence interval, 0.124-0.539, P < .001), respectively. Specialized HETF was associated with a significant decrease in the prevalence of pneumonia (24.1% vs 14.2%), respiratory failure (7.3% vs 1.9%), urinary tract infection (11.3% vs 4.9%), and anemia (3.9% vs 0%) requiring hospitalization. The average yearly cost of hospital treatment decreased from $764.65 per patient to $142.66 per year per patient. CONCLUSIONS:The specialized HETF care program reduces morbidity and costs related to long-term enteral feeding at home.

BACKGROUND AND AIM/OBJECTIVE: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/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.