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Completed

NCT Number: NCT03493204

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

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.

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Key information

Conditions

Hepatic Encephalopathy Ascites Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Cirrhosis Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal delivery

Other

The food will be pre-packaged for storage and patient will prepare these meals at home

Standard pamphlet with Dietary Advice

Other

Explains how to maintain a low-sodium diet

Primary outcomes

  1. Number of therapeutic paracenteses

    Time frame: From date of randomization until 12 weeks

    Number of paracenteses

Secondary outcomes

  1. Change in Quality of life

    Time frame: 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 outcomes

  1. Number of hospital-bed days in 12 weeks

    Time frame: From date of randomization until 12 weeks

    The number of days the participants were hospitalized after randomization

  2. Change in diuretic dose

    Time frame: baseline, week 12

    The dose amount changes the participant's medications that are considered diuretics

  3. Change in frailty measures

    Time frame: 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.

  4. Change in frailty measures

    Time frame: baseline, week 12

    Change in time taken to walk 5 meters (walk speed measured in meters per second)

  5. Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2018
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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