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

Not Applicable

Completed

• Conditions: Ascites; Liver Diseases; Hepatic Encephalopathy; Cirrhosis
• Interventions: Other: Meal delivery; Other: Standard pamphlet with Dietary Advice

• Registration Number: NCT03493204
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Study Start: 2018-04-24
• Status Verified: 2019-08
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-delivered, salt restricted	Meal delivery	Meal description: salt-restricted (1500 mg to 2000 mg daily), \> 2100 kilocalorie, high protein (\>80 g daily) in addition to receiving standard pamphlet receipt
Dietary Advice	Standard pamphlet with Dietary Advice	Standard of care, advice on salt-restriction using standard pamphlet receipt

Primary Outcome Measures

Name	Time	Method
Number of therapeutic paracenteses	From date of randomization until 12 weeks	Number of paracenteses

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life	baseline, week 12	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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States