Ammonia Metabolism Assessed by Ammonia Infusion

Liver Failure, Chronic Clinical Trial

— NH4 inf  

Official title:

Ammonia Metabolism Assessed by Ammonia Infusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585672
• Other study ID #: 1-16-02-297-20
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: University of Aarhus
• Contact: Peter Lykke Eriksen, MD PhD
• Phone: +45 23715703
• Email: ple[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ammonia; Metabolic Disorder
• End Stage Liver Disease
• Liver Failure
• Liver Failure, Chronic
• Metabolic Diseases

Intervention

Other:
• Ammonia infusion
Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)

Locations

Country	Name	City	State
Denmark	Department of Hepatology & Gastroenterology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clearance (L/min) and production (micromol/min) of ammonia	A physiological parameter	2 years
Secondary	Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents	Proof of concept	2 years