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Design and rationale of a randomized-controlled trial of home-delivered meals for the management of symptomatic ascites:the SALTYFOOD trial

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Gastroenterology Report 2019年第2期7卷 146-149,I0002页

作者： Elliot B.Tapper jad baki Scott Hummel Anna Lok Division of Gastroenterology and Hepatology Department of Internal MedicineUniversity of MichiganAnn ArborMichiganUSA University of Michigan Ann ArborMichiganUSA Division of Cardiology Department of Internal Medicine University of MichiganAnn ArborMichiganUSA

Background:When patients with cirrhosis develop ascites,it is associated with sharply increasedmortality and healthcare utilization with decreased quality of *** salt restriction is first-line therapy for ascites but it is limited by poor ***:We will recruit 40 patients with cirrhosis and ascites who have received a recent paracentesis or hospitalization for a 1:1 randomized trial of standard care(education on salt restriction)versus home-delivered *** primary outcome is the number of paracenteses needed over 12 *** outcomes include hospital-bed days,health-related quality of life(HRQOL,Ascites Symptom Inventory-7 and Visual Analogue Scale)and performance on batteries of physical function including hand grip(kg)and walk speed(m/s).All subjects follow up through a series of calls where any paracenteses,hospital readmissions,weight changes and diuretic dosage changes are *** a final Week 12 visit,knowledge of dietary sodium intake,quality of life and frailty are reassessed,and satisfaction with the meal-delivery program is *** comparison testing will be conducted between the two ***:A nutritionally standardized meal-delivery program for patients with cirrhosis and ascites post discharge has a variety of potential patient-based benefits,including the effective management of ascites,reduction of healthcare utilization and improvement of *** have three core ***,patients will report interest in and satisfaction with a home-delivered meals ***,subjects on a salt-restricted(2 g sodium)meal-delivery program will have fewer therapeutic paracenteses and all-cause readmissions than subjects receiving standard of ***,subjects on a saltrestricted(2 g sodium)meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.

关键词： Readmissions malnutrition cirrhosis nutrition sodium

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Medically tailored meals for the management of symptomatic ascites:the SALTYFOOD pilot randomized clinical trial

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Gastroenterology Report 2020年第6期8卷 453-456,I0002页

作者： Elliot B.Tapper jad baki Samantha Nikirk Scott Hummel Sumeet K.Asrani Anna SLok Division of Gastroenterology and Hepatology University of MichiganAnn ArborMIUSA Gastroenterology Section VA Ann Arbor Healthcare SystemAnn ArborMIUSA Department of Biostatistics University of MichiganAnn ArborMIUSA Baylor University Medical Center DallasTXUSA

Background:Ascites is a costly,morbid complication of *** a low-sodium diet is central to the clinical management of ascites,its efficacy is limited by poor *** aimed to determine the feasibility and impact of lowsodium medically tailored meals(MTM)***:We enrolled 40 persons with cirrhosis and ascites at the time of a paracentesis in a 12-week,1:1 randomized trial of standard of care(SOC)(low-sodiumdiet educational handout)or MTM with2,100 kcal,and>80 g of protein including a nocturnal protein *** determined the proportion of eligible candidates recruited and adherence to *** primary outcome was the number of paracenteses performed during weeks *** also collected ascites-specific quality-of-life(ASI-7)***:The median age of the enrolled subjects was 54(IQR,47-63)years,46%were female,with median MELD-Na 18(IQR,11-23)and albumin 2.7(IQR,2.5-3.3)g/*** baseline,subjects reported a median of two(IQR,1-3)paracenteses in the prior 4 *** to the meal schedule was excellent save for when hospitalizations *** 12 weeks,patients in the MTM arm required fewer paracenteses per week than those in the SOC group[median(IQR):0.34(0.14-0.54)vs 0.45(0.25-0.64)].During the trial,four(20%)SOC patients died,whereas two(10%)died and one(5%)was transplanted in the MTM ***-specific quality of life improved to a greater degree in the MTM arm compared to the SOC arm,by 25%(IQR,-11%to 61%)vs 13%(IQR,-28%to 54%).Conclusion:A trial of MTM for persons with ascites is feasible and potentially *** arms experienced benefits,highlighting the role for improved education and closer monitoring in this challenging condition.

关键词： cirrhosis ascites paracentesis sodium

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ERRATUM:Design and rationale of a randomized–controlled trial of home-delivered meals for the management of symptomatic ascites:the SALTYFOOD trial

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Gastroenterology Report 2019年第2期7卷 150-150,I0002页

作者： Elliot B Tapper jad baki Scott Hummel Anna Lok Division of Gastroenterology and Hepatology Department of Internal Medicine University of Michigan Ann Arbor Michigan USA. University of Michigan Ann Arbor Michigan USA. Division of Cardiology Department of Internal Medicine University of Michigan Ann Arbor Michigan USA.

[This corrects the article DOI: 10.1093/gastro/goz005.].

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