Ammonia Metabolism Assessed by Ammonia Infusion

Not Applicable

• Conditions: Ammonia; Metabolic Disorder; Liver Failure, Chronic
• Interventions: Other: Ammonia infusion

• Registration Number: NCT04585672
• Lead Sponsor: Aarhus University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-19
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy and Cirrhosis	Ammonia infusion	Ammonia infusion with and without ammonia targeting

Primary Outcome Measures

Name	Time	Method
Rate of clearance (L/min) and production (micromol/min) of ammonia	2 years	A physiological parameter

Secondary Outcome Measures

Name	Time	Method
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents	2 years	Proof of concept

Trial Locations

Locations (1)

Department of Hepatology & Gastroenterology; 🇩🇰 Aarhus, Denmark