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

Launched by THE CLEVELAND CLINIC · Sep 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether taking a special protein supplement called Ensure Enlive in the late evening and early morning can help reduce hospital readmissions for patients with hepatic encephalopathy, a serious condition that can occur in people with liver disease. The researchers believe that this protein supplement may help improve the health of the muscles and lower a harmful substance called ammonia in the blood, which contributes to the confusion and other symptoms seen in hepatic encephalopathy.

To be eligible for this trial, participants must be adults over 18 years old with a diagnosis of cirrhosis (severe liver disease) and have had at least one hospital stay for hepatic encephalopathy in the last year. Participants can expect to take the protein supplement for six months and will be monitored closely during this time. This trial is currently looking for participants, and it's important to know that certain medical conditions and treatments may exclude someone from joining, such as severe kidney problems, cancer, or specific medications that affect muscle health.

Gender

ALL

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.