Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Gastrointestinal, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | April 24, 2018 |
| End Date: | April 2021 |
| Contact: | Sam Nikirk |
| Email: | samjwalk@med.umich.edu |
| Phone: | 734-232-4182 |
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.
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.
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
- Diabetes Mellitus
- Uncontrolled hepatic encephalopathy
We found this trial at
1
site
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
