Hepatic EncephalopathyNCT03493204
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
A study testing Meal delivery and Standard pamphlet with Dietary Advice in people with Hepatic Encephalopathy and Ascites, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Ascites, Liver Diseases
- What is being tested?
- Meal delivery and Standard pamphlet with Dietary Advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
- Being tested
- Meal delivery, Standard pamphlet with Dietary Advice
- Keywords
- Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
- Medical subject headings
- Hepatic Encephalopathy, Ascites, Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal deliveryOther
The food will be pre-packaged for storage and patient will prepare these meals at home
Standard pamphlet with Dietary AdviceOther
Explains how to maintain a low-sodium diet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Meal delivery |
| Dietary Advice | Active comparator | Standard of care, advice on salt-restriction using standard pamphlet receipt Receives: Other: Standard pamphlet with Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of therapeutic paracenteses
Number of paracenteses
Measured: From date of randomization until 12 weeks
Secondary outcomes (1)
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.
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start24 Apr 2018
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493204
- Sponsor's protocol ID
- HUM00141457
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
- ClinicalTrials.gov ID
- NCT03493204
- Acronym / sponsor ID
- HUM00141457
- Conditions
- Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
- Keywords
- Hepatic Encephalopathy, Ascites, Liver Diseases, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-delivered, salt restricted | Experimental | Other: Meal deliveryMeal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt |
| Dietary Advice | Active comparator | Other: Standard pamphlet with Dietary AdviceStandard of care, advice on salt-restriction using standard pamphlet receipt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult 18 years or older of age
- Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
- 3) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal deliveryThe food will be pre-packaged for storage and patient will prepare these meals at home | Other | Home-delivered, salt restricted |
| Standard pamphlet with Dietary AdviceExplains how to maintain a low-sodium diet | Other | Dietary Advice |
Primary outcome
Number of therapeutic paracenteses
Time frame: From date of randomization until 12 weeks
Number of paracenteses
1 secondary outcome
Change in Quality of life
Time frame: baseline, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Tapper principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal delivery and Standard pamphlet with Dietary Advice in people with Hepatic Encephalopathy and Ascites, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of therapeutic paracenteses (time frame: From date of randomization until 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.