NCT03493204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

April 3, 2018

Last Update Submit

August 28, 2019

Conditions

Hepatic EncephalopathyAscitesLiver DiseasesCirrhosis

Keywords

Hepatic EncephalopathyAscitesLiver DiseasesCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of therapeutic paracenteses

    Number of paracenteses

    From date of randomization until 12 weeks

Secondary Outcomes (1)

  • Change in Quality of life

    baseline, week 12

Other Outcomes (5)

  • Number of hospital-bed days in 12 weeks

    From date of randomization until 12 weeks

  • Change in diuretic dose

    baseline, week 12

  • Change in frailty measures

    baseline, week 12

  • +2 more other outcomes

Study Arms (2)

Home-delivered, salt restricted

EXPERIMENTAL

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

Other: Meal delivery

Dietary Advice

ACTIVE COMPARATOR

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

Other: Standard pamphlet with Dietary Advice

Interventions

Meal deliveryOTHER

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

Home-delivered, salt restricted
Standard pamphlet with Dietary AdviceOTHER

Explains how to maintain a low-sodium diet

Dietary Advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • \) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hepatic EncephalopathyAscitesLiver DiseasesFibrosis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Elliot Tapper

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 10, 2018

Study Start

April 24, 2018

Primary Completion

August 19, 2019

Study Completion

August 19, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

US(1)