Ammonia Metabolism Assessed by Ammonia Infusion (NH4 inf)

Aarhus University Hospital

Status: Unknown

Conditions: Liver Failure, Chronic; Ammonia; Metabolic Disorder

Treatments: Other: Ammonia infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04585672

1-16-02-297-20

Details and patient eligibility

About

The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Healthy controls:

• Alcohol < 40g/day
• BMI < 30
• Diseased or medicated

Inclusion Criteria - Patients with cirrhosis:

• Child-Pugh A or B cirrhosis
• BMI < 30

Exclusion Criteria:

• Child-Pugh score C
• Kidney failure (eGFR < 60 mL/min/1.73m2)
• Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy
• Acute bacterial infection
• Cancer
• Diabetes
• Ammonia-targeted treatment of hepatic encephalopathy other than lactulose (including Rifaximin and branched-chain amino acids)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Healthy and Cirrhosis

Other group

Description:

Ammonia infusion with and without ammonia targeting

Treatment:

Other: Ammonia infusion