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COMPLETEDNA

Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial

NCT03493204•University of Michigan

Summary

The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult 18 years or older of age
•Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
•1. liver biopsy, OR
•2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
•3. 2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score \>13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) \>2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
•3\) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days

Exclusion Criteria

•Language barriers that cannot be surmounted with in-person interpreters
•Estimated life expectancy \< 3 months
•Pregnancy (self-reported)
•Unable or unwilling to provide consent
•History of liver transplant
•Planned discharge to nursing facility
•Anuria or serum creatinine \> 2.0 mg/dL
•Uncontrolled hepatic encephalopathy

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

April 24, 2018

Primary Completion Date

August 19, 2019

Completion Date

August 19, 2019

Last Updated

August 30, 2019

Enrollment

ACTUAL participants

Conditions

Hepatic EncephalopathyAscitesLiver DiseasesCirrhosis

Interventions

Meal delivery

OTHER

Standard pamphlet with Dietary Advice

OTHER

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RECRUITINGNA

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

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Liver Diseases, AlcoholicAlcohol Use Disorder+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial

Inclusion Criteria

Exclusion Criteria

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

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Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement