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

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Updated on 18 February 2022

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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 Identifier	NCT04096014
Sponsor	The Cleveland Clinic
Last Modified on	18 February 2022

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