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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

Qualifiers

> 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ensure Enlive
  • Standard Of Care

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators