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

Primary Purpose

Hepatic Encephalopathy, Ascites, Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal delivery
Standard pamphlet with Dietary Advice
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-delivered, salt restricted

Dietary Advice

Arm 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

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

Outcomes

Primary Outcome Measures

Number of therapeutic paracenteses
Number of paracenteses

Secondary Outcome Measures

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.

Full Information

First Posted
April 3, 2018
Last Updated
August 28, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03493204
Brief Title
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Official Title
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
August 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
Keywords
Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-delivered, salt restricted
Arm Type
Experimental
Arm 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
Arm Title
Dietary Advice
Arm Type
Active Comparator
Arm Description
Standard of care, advice on salt-restriction using standard pamphlet receipt
Intervention Type
Other
Intervention Name(s)
Meal delivery
Intervention Description
The food will be pre-packaged for storage and patient will prepare these meals at home
Intervention Type
Other
Intervention Name(s)
Standard pamphlet with Dietary Advice
Intervention Description
Explains how to maintain a low-sodium diet
Primary Outcome Measure Information:
Title
Number of therapeutic paracenteses
Description
Number of paracenteses
Time Frame
From date of randomization until 12 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
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.
Time Frame
baseline, week 12
Other Pre-specified Outcome Measures:
Title
Number of hospital-bed days in 12 weeks
Description
The number of days the participants were hospitalized after randomization
Time Frame
From date of randomization until 12 weeks
Title
Change in diuretic dose
Description
The dose amount changes the participant's medications that are considered diuretics
Time Frame
baseline, week 12
Title
Change in frailty measures
Description
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.
Time Frame
baseline, week 12
Title
Change in frailty measures
Description
Change in time taken to walk 5 meters (walk speed measured in meters per second)
Time Frame
baseline, week 12
Title
Quality of life
Description
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
Time Frame
baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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