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

University of Michigan

Status: Completed

Conditions: Hepatic Encephalopathy; Cirrhosis; Liver Diseases; Ascites

Treatments: Other: Meal delivery; Other: Standard pamphlet with Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT03493204

HUM00141457

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Home-delivered, salt restricted

Experimental group

Description:

Meal description: salt-restricted (1500 mg to 2000 mg daily), \> 2100 kilocalorie, high protein (\>80 g daily) in addition to receiving standard pamphlet receipt

Treatment:

Other: Meal delivery

Dietary Advice

Active Comparator group

Description:

Standard of care, advice on salt-restriction using standard pamphlet receipt

Treatment:

Other: Standard pamphlet with Dietary Advice