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

NCT ID: NCT03493204

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2019-08-19

Brief Summary

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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

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Conditions

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Hepatic Encephalopathy Ascites Liver Diseases Cirrhosis

Keywords

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Hepatic Encephalopathy Ascites Liver Diseases Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home-delivered, salt restricted

Meal description: salt-restricted (1500 mg to 2000 mg daily), \> 2100 kilocalorie, high protein (\>80 g daily) in addition to receiving standard pamphlet receipt

Group Type EXPERIMENTAL

Meal delivery

Intervention Type OTHER

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

Dietary Advice

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

Group Type ACTIVE_COMPARATOR

Standard pamphlet with Dietary Advice

Intervention Type OTHER

Explains how to maintain a low-sodium diet

Interventions

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Meal delivery

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

Intervention Type OTHER

Standard pamphlet with Dietary Advice

Explains how to maintain a low-sodium diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Elliot B. Tapper

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elliot Tapper

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00141457

Identifier Type: -

Identifier Source: org_study_id