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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    40
  • sponsor
    The Cleveland Clinic
Updated on 18 February 2022
ct scan
encephalopathy
liver disease
cirrhosis
protein supplement
hyperammonemia

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.

Details
Condition Hepatic Encephalopathy
Treatment Standard of Care, Ensure Enlive
Clinical Study IdentifierNCT04096014
SponsorThe Cleveland Clinic
Last Modified on18 February 2022

Eligibility

Yes No Not Sure

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
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