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

Completed · Not applicable

Conditions studied: Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis

In brief

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.

Key facts

Study ID

NCT03493204

Run by

University of Michigan

People needed

44

Starts

2018-04-24

Expected to finish

2019-08-19

Last updated by the study team

2019-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult 18 years or older of age
• Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
• liver biopsy, OR
• history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
• 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

You may not qualify if…

• 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

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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