None listed
Conditions
Brief summary
To determine whether an unrestricted sodium diet, compared to a low sodium diet as prescribed by in patient hospital dietician initially and then delivered by participants at home over 30 days improves handgrip strength without increasing the need for large-volume paracentesis in patients with decompensated cirrhosis and ascites.
Interventions
The intervention administered is an unrestricted sodium diet in patients with cirrhosis and ascites (compared with a sodium restricted diet which is current standard of care).
The diet plan will be provided by the hospital kitchen and exact meals are under their discretion on the day with participants being able to select out of options on their menu. The intervention will be a high protein diet without sodium restriction.
Whilst participants are inpatients, the meals will be provided by the h
The intervention administered is an unrestricted sodium diet in patients with cirrhosis and ascites (compared with a sodium restricted diet which is current standard of care). The diet plan will be provided by the hospital kitchen and exact meals are under their discretion on the day with participants being able to select out of options on their menu. The intervention will be a high protein diet without sodium restriction. Whilst participants are inpatients, the meals will be provided by the hospital. On discharge the meals will be provided by the participants themselves and they will receive verbal and written information from their dietician regarding a high protein diet including written sample meal plan.
Sponsors
Sunshine Coast Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients 18 years and over • Current diagnosis of cirrhosis, based on imaging, fibroscan, or liver biopsy • Clinical evidence of ascites consistent with portal hypertension serum- ascites albumin gradient >11g/dL
Exclusion criteria
• Patients with a history of large volume paracentesis • Any neurological or musculoskeletal condition impacting hand grip strength • Patients admitted to the Intensive Care Unit • Patients with a history of congestive cardiac failure or chronic renal impairment • Patient unable to give informed consent • Patient on nasogastric feeding • Patients with Barcelona Clinic Liver Cancer (BCLC) stage C and D hepatocellular carcinoma (HCC) • Pregnant patients
Outcome results
None listed