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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493204
• Other study ID #: HUM00141457
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Liver Diseases

Intervention

Other:
• Meal delivery
The food will be pre-packaged for storage and patient will prepare these meals at home
• Standard pamphlet with Dietary Advice
Explains how to maintain a low-sodium diet

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in diuretic dose	The dose amount changes the participant's medications that are considered diuretics	baseline, week 12
Other	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
Other	Change in frailty measures	Change in time taken to walk 5 meters (walk speed measured in meters per second)	baseline, week 12
Other	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
Primary	Number of therapeutic paracenteses	Number of paracenteses	From date of randomization until 12 weeks
Secondary	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