Comparing mixed oil to soybean oil lipid emulsion in patients on home parenteral nutrition: a pilot prospective double-blind, crossover, randomized trial.

BACKGROUND: Home parenteral nutrition (HPN) can be associated with increased liver enzymes, catheter-related bloodstream infections (CRBSI), and hospitalizations. Mixed oil (MO) versus soybean oil (SO) lipid emulsion reduces risks in hospitalized patients, but there are no randomized double-blinded controlled trials in HPN. Therefore, the primary objective was to test the study's feasibility such as recruitment and retention in the HPN population and the secondary objective was to assess changes in liver enzymes between MO and SO as well as other clinical and biochemical outcomes. METHODS: This 13-month prospective double-blind crossover randomized pilot trial took place in Toronto, Canada. Participants were HPN patients who were a part of the HPN program at Toronto General Hospital. We recruited patients from the HPN program. HPN patients receiving SO were randomized to either MO or SO, and the study duration was 6 months in each arm (MO or SO) with a 1-month washout period resuming SO. As this is a crossover trial design, the patient is his/her own control. The main outcome measures were descriptions of study feasibility, namely the study recruitment and retention. We also collected biochemical parameters, CRSBI, hospitalization rate, antibiotic use, and mortality. Demographic, nutritional, clinical, and laboratory data were collected at baseline, 3 and 6 months of each arm. The primary analysis population was defined as the per-protocol population who completed the trial including all lipid measurements. RESULTS: A total of 65 HPN patients were assessed, and 60 met the inclusion criteria for the study. Thirty-five percent (21/60) were randomized using a computer-generated random number sequence generator: 10 participants were randomized to receive SO first while 11 were randomized to receive MO first. At 13 months, 3/10 who received SO first completed the study, whereas 9/11 who received MO first completed the study. This did not meet our a priori criteria for success in recruitment and retention. Between types of lipid emulsions, there were no significant differences in changes in liver enzymes or biochemical and clinical outcomes, despite significant changes in plasma free fatty acid composition reflecting MO or SO. CONCLUSIONS: Overall, this pilot trial demonstrated that the use of a prospective double-blind, crossover, randomized trial design was not feasible to conduct in the HPN population because of difficulties in recruiting and retaining patients. In addition, there was no significant impact of MO versus SO lipid emulsion on liver enzymes or most parameters. The lack of significance may be attributed to low sample size from low recruitment and high drop-out rate, short study duration (6 months/arm), and complex care. In a future definitive trial, a multicenter study of longer duration and a larger sample size is recommended, and drop-outs may be reduced by using a parallel study design. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02796833. Registered on 13 June 2016-retrospectively registered.

Home parenteral nutrition in older vs younger patients: Clinical characteristics and outcomes.

BACKGROUND: There is a demographic shift toward older patients receiving home parenteral nutrition (HPN), but data on clinical outcomes are limited. The objective of this study was to determine differences between older and younger HPN patients in regard to HPN indications, prescriptions, and outcomes over the first 2 years receiving HPN. METHODS: This was a retrospective analysis of prospectively collected data from HPN adult patients entered in the Canadian HPN Registry. New HPN patients enrolled between 2003 and 2017 and receiving HPN for at least 2 years were selected. Data included demographics, PN prescriptions, catheter-related bloodstream infections (CRBSIs) over the past year, survival, and quality of life based on Karnofsky Performance Status (KPS). RESULTS: Four hundred two patients were included: 184 patients were ≥60 years old, and 219 patients were between 18 and 59 years old. There were no differences in the main indications for HPN, body mass index (BMI), and PN prescriptions at baseline. At 2 years, younger patients received more energy from PN than older patients (27.9 vs 19.6 kcal/kg; P < .001), but BMI remained comparable. There were fewer CRBSIs in the older group (20% vs 36%, P = .0023), but 78% of younger patients remained alive vs 69% in the older group (P = .0401). In those alive, the proportion of patients continuing to receive HPN was comparable and the proportion of patients with a KPS ≥60. CONCLUSIONS: Older HPN patients have similar clinical characteristics as younger patients but have fewer CRBSIs and higher 2-year mortality.

Olive oil-based lipid emulsion is noninferior to soybean oil-based lipid emulsion in the acute care setting: A double-blind randomized controlled trial.

OBJECTIVES: Olive oil (OO)-based intravenous lipid emulsion (IVLE) may have biological advantages for nutrition and inflammation status compared with soybean oil (SO)-based IVLE. We aimed to compare prealbumin levels during infusion of OO- or SO-based IVLE in patients receiving parenteral nutrition in the acute-care setting. METHODS: In this prospective, noninferiority, double blind randomized controlled efficacy trial, patients received either OO-based or SO-based IVLE after providing consent. Biochemical and nutrition parameters were collected at baseline and at 7 to 10 d after initiation of parenteral nutrition. Results are expressed as means (standard deviations). RESULTS: A total of 210 patients completed the study: 102 patients in the SO-based IVLE group and 108 patients in the OO-based IVLE group. Both groups had a significant increase in prealbumin levels from baseline (SO: 0.10 [0.06] versus 0.15 [0.08] g/L; P < 0.0001; OO: 0.11 [0.06] versus 0.16 [0.08] g/L; P < 0.0001), but mean changes between groups were not different (P = 0.53). OO-based IVLE was noninferior to SO-based IVLE in maintaining or increasing serum prealbumin levels, with 20% as the noninferiority margin at follow-up (least square geometric mean ratio [95% CI], 1.10 [0.83,1.47]; P = 0.50). There was a significant improvement in C-reactive protein levels from baseline within each group (SO: 83.24 [69.72] versus 53.4 [59.78] mg/dL; P < 0.0001; OO: 85.13 [68.14] versus 58.75 [60.11] mg/dL; P = 0.004), but mean changes between the groups were not different (P = 0.836). Mortality, length of stay, and infection rates were not different for both groups. CONCLUSIONS: In this study, OO-based IVLE was not inferior to SO-based IVLE in maintaining or increasing the prealbumin level. The improvement of C-reactive protein levels and other clinical outcomes were not different for both groups.

Validation of the Scored Patient-Generated Subjective Global Assessment (PG-SGA) in Thai Setting and Association with Nutritional Parameters in Cancer Patients

Background: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is a multidimensional tool to assess malnutrition and risk factors. The objectives of this study are to determine the validity of the Thai version of the Scored PG-SGA (Thai PG-SGA) and examine the correlations with selected nutritional parameters. Methods: This observational analytic study included 195 cancer patients aged greater than 18 years at a university-affiliated hospital in Bangkok, Thailand. All patients were assessed for nutritional status by Thai PG-SGA in comparison to subjective global assessment (SGA). Anthropometry, body composition, and hand grip strength were evaluated. Results: According to PG-SGA global assessment categories, 39% (75) of 195 cancer patients were well nourished, 27% (53) were moderately malnourished and 34% (67) of patients were severely malnourished. Thai PG-SGA had a sensitivity of 99.1% and a specificity of 86.0% at predicting SGA classification. PG-SGA numerical scores were significantly different between well-nourished and malnourished groups (4.2 ± 2.4 Vs 16.3 ± 4.9; p < 0.001). The PG-SGA scores, nutritional status assessed by PG-SGA, and nutritional status assessed by SGA were correlated with weight, % weight loss in one month, body mass index, body fat, and hand grip strength (p < 0.001) respectively. Conclusions: Thai PG-SGA showed high sensitivity and good specificity in predicting malnutrition in Thai cancer patients. This tool demonstrated the correlations with anthropometric parameters, body composition, and muscle strength.

Effect of Rice, Wheat, and Mung Bean Ingestion on Intestinal Gas Production and Postprandial Gastrointestinal Symptoms in Non-Constipation Irritable Bowel Syndrome Patients.

The aim of this study is to evaluate the effect of rice, mung bean, and wheat noodle ingestion on intestinal gas production and postprandial gastrointestinal (GI) symptoms in non-constipation irritable bowel syndrome (IBS) patients. METHODS: Twenty patients (13 F, 46 ± 11 y) underwent 8 h breath test studies and GI symptom evaluations after standard rice, wheat, or mung bean noodle meals at 8:00 a.m. in a randomized crossover study with a 1-week washout period. The same meal was ingested at 12:00 p.m. RESULTS: The H2 and CH4 concentration in the breath samples were similar at baseline (rice:wheat:mung bean, H2 = 3.6 ± 0.5:4.1 ± 0.5:4.0 ± 0.7 ppm, CH4 = 1.3 ± 0.3:2.1 ± 0.4:1.9 ± 0.4 ppm, p > 0.05). Beginning at the fifth hour after breakfast, H2 and CH4 concentrations significantly increased after wheat compared to rice and mung bean (8 h AUC H2 = 4120 ± 2622:2267 ± 1780:2356 ± 1722, AUC CH4 = 1617 ± 1127:946 ± 664:943 ± 584 ppm-min, respectively) (p < 0.05). Bloating and satiety scores significantly increased after wheat compared to rice (p < 0.05), and increased but did not reach statistical significance compared to mung bean (p > 0.05). A higher bloating score after wheat compared to rice and mung bean was observed clearly after lunch but not after breakfast. CONCLUSION: Wheat ingestion produced more intestinal gas and more bloating and satiety scores compared to rice and mung bean, especially after lunch. This provides insight into the role of intestinal gas in the development of bloating symptoms in IBS.

The Impact of Macro-and Micronutrients on Predicting Outcomes of Critically Ill Patients Requiring Continuous Renal Replacement Therapy.

Critically ill patients with acute kidney injury (AKI) who receive renal replacement therapy (RRT) have very high mortality rate. During RRT, there are markedly loss of macro- and micronutrients which may cause malnutrition and result in impaired renal recovery and patient survival. We aimed to examine the predictive role of macro- and micronutrients on survival and renal outcomes in critically ill patients undergoing continuous RRT (CRRT). This prospective observational study enrolled critically ill patients requiring CRRT at Intensive Care Unit of King Chulalongkorn Memorial Hospital from November 2012 until November 2013. The serum, urine, and effluent fluid were serially collected on the first three days to calculate protein metabolism including dietary protein intake (DPI), nitrogen balance, and normalized protein catabolic rate (nPCR). Serum zinc, selenium, and copper were measured for micronutrients analysis on the first three days of CRRT. Survivor was defined as being alive on day 28 after initiation of CRRT.Dialysis status on day 28 was also determined. Of the 70 critically ill patients requiring CRRT, 27 patients (37.5%) survived on day 28. The DPI and serum albumin of survivors were significantly higher than non-survivors (0.8± 0.2 vs 0.5 ±0.3g/kg/day, p = 0.001, and 3.2±0.5 vs 2.9±0.5 g/dL, p = 0.03, respectively) while other markers were comparable. The DPI alone predicted patient survival with area under the curve (AUC) of 0.69. A combined clinical model predicted survival with AUC of 0.78. When adjusted for differences in albumin level, clinical severity score (APACHEII and SOFA score), and serum creatinine at initiation of CRRT, DPI still independently predicted survival (odds ratio 4.62, p = 0.009). The serum levels of micronutrients in both groups were comparable and unaltered following CRRT. Regarding renal outcome, patients in the dialysis independent group had higher serum albumin levels than the dialysis dependent group, p = 0.01. In conclusion, in critically ill patients requiring CRRT, DPI is a good predictor of patient survival while serum albumin is a good prognosticator of renal outcome.