ArticleGastroenterology report2019
Design and rationale of a randomized-controlled trial of home-delivered meals for the management of symptomatic ascites: the SALTYFOOD trial.
Article in Gastroenterology report, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Medically tailored meals for the management of symptomatic ascites: the SALTYFOOD pilot randomized clinical trial.Gastroenterology report · 2020Article
- A Smartphone App to Manage Cirrhotic Ascites Among Outpatients: Feasibility Study.JMIR medical informatics · 2020Article
- Do Nutritional Interventions Improve the Outcomes of Patients with Cirrhosis and Ascites: A Systematic Review of Randomized Trials.Current hepatology reports · 2020Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: When patients with cirrhosis develop ascites, it is associated with sharply increased mortality and healthcare utilization with decreased quality of life. Dietary salt restriction is first-line therapy for ascites but it is limited by poor adherence. Methods: 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 meals. Our primary outcome is the number of paracenteses needed over 12 weeks. Secondary 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 recorded. In 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 evaluated. Paired comparison testing will be conducted between the two arms. Discussion: 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 HRQOL. We have three core hypotheses. First, patients will report interest in and satisfaction with a home-delivered meals program. Second, 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 care. Third, subjects on a salt-restricted (2 g sodium) meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.
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