Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encep
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrho
| Condition(s) | Hepatic Encephalopathy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass. |
| Who can participate | 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 muscl |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | The Cleveland Clinic |
| Locations | Cleveland, Ohio, United States |
| Start date | 2019-09-16 |
| NCT ID | NCT04096014 |
| Official listing | https://clinicaltrials.gov/study/NCT04096014 |