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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis

Intervention / Treatment
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* Other: Meal delivery
* Other: Standard pamphlet with Dietary Advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-delivered, salt restricted<br>Meal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt | Other: Meal delivery<br>* The food will be pre-packaged for storage and patient will prepare these meals at home<br>|
| Active Comparator: Dietary Advice<br>Standard of care, advice on salt-restriction using standard pamphlet receipt | Other: Standard pamphlet with Dietary Advice<br>* Explains how to maintain a low-sodium diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of therapeutic paracenteses | Number of paracenteses | From date of randomization until 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | Measured by Ascites Symptom Inventory (ASI-7). This is a 7 question scale that measures the subject's symptoms with a value from 0-4 (0=does not apply / 4=very strong applies). The higher the subject's score the worse the subject's symptoms. The mean change will be compared between groups. | baseline, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis