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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Hepatic Encephalopathy; Cirrhosis; Ascites
• Intervention / Treatment: Other: Meal delivery; Other: Standard pamphlet with Dietary Advice

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-delivered, salt restricted; 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; The food will be pre-packaged for storage and patient will prepare these meals at home
Active Comparator: Dietary Advice; Standard of care, advice on salt-restriction using standard pamphlet receipt	Other: Standard pamphlet with Dietary Advice; Explains how to maintain a low-sodium diet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital-bed days in 12 weeks	The number of days the participants were hospitalized after randomization	From date of randomization until 12 weeks
Change in diuretic dose	The dose amount changes the participant's medications that are considered diuretics	baseline, week 12
Change in frailty measures	Change in the hand grip strength using a hand-held dynamometer. The device will be squeezed 3 times with their dominant hand and the force measured in kilograms. The best recorded value (highest force number) will be their value.	baseline, week 12
Change in frailty measures	Change in time taken to walk 5 meters (walk speed measured in meters per second)	baseline, week 12
Quality of life	Change in Visual Analog Scale. The subject selects how their health is today by marking an X on the scale from 0-100; 0= worst imaginable health state / 100= best imaginable health state	baseline, week 12

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elliot Tapper, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cirrhosis; Liver Diseases; Ascites; Hepatic Encephalopathy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic; Liver Diseases; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Ascites
• Other Study ID Numbers: HUM00141457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No