Ascites, Cirrhosis, Hepatic Encephalopathy, Liver Diseases
Conditions
Keywords
Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
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.
Interventions
OTHERMeal delivery
The food will be pre-packaged for storage and patient will prepare these meals at home
OTHERStandard pamphlet with Dietary Advice
Explains how to maintain a low-sodium diet
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of therapeutic paracenteses | From date of randomization until 12 weeks | Number of paracenteses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital-bed days in 12 weeks | From date of randomization until 12 weeks | The number of days the participants were hospitalized after randomization |
| Change in diuretic dose | baseline, week 12 | The dose amount changes the participant's medications that are considered diuretics |
| Change in frailty measures | baseline, week 12 | 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. |
| Quality of life | baseline, week 12 | 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 |
Countries
United States
Outcome results
None listed