Protein supplement to reduce hospital readmissions for liver disease patients

Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

This study is testing if a protein supplement can help liver disease patients who have had hospital stays for brain issues feel better and avoid going back to the hospital.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT04096014 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a nutritional intervention using a protein supplement called Ensure Enlive on patients with hepatic encephalopathy due to cirrhosis. The study aims to reduce readmission rates by administering the supplement in late evening and early morning to improve lean body mass and decrease skeletal muscle proteolysis. Participants will be monitored over a 6-month period to assess the impact of this intervention on recurrent hepatic encephalopathy. The trial includes patients who have had at least one hospitalization for hepatic encephalopathy in the past year.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a diagnosis of cirrhosis and a history of hospitalization for hepatic encephalopathy within the last year.

Not a fit: Patients with severe liver dysfunction (MELD score > 35), active malignancies, or uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly lower the rates of hospital readmissions for patients suffering from hepatic encephalopathy.

How similar studies have performed: While similar nutritional interventions have been explored, this specific approach combining late evening and early morning protein supplementation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* \> 18 years of age
* cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
* at least 1 hospitalization for documented HE within the last 12 months.
* abdominal CT scan anytime in the past

Exclusion Criteria:

* Patients with MELD score \> 35
* end stage organ failure (major dysfunction requiring organ support)
* kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
* active malignancy
* uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism
* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
* recent gastrointestinal surgery within past 12 months
* ongoing infection (positive blood or other body fluid cultures)
* active gastrointestinal bleeding.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Annette C Bellar

Conditions: Hepatic Encephalopathy