Ammonia Metabolism Assessed by Ammonia Infusion

Aarhus University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ammonia; Metabolic Disorder Liver Failure, Chronic

Interventions

Ammonia infusionOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Department of Hepatology & Gastroenterology

Aarhus, Denmark

RECRUITING

Outcomes

Primary Outcomes

Rate of clearance (L/min) and production (micromol/min) of ammonia

A physiological parameter

Time frame: 2 years

Secondary Outcomes

Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents

Proof of concept

Time frame: 2 years

Central Contacts

Peter Lykke Eriksen, MD PhD

CONTACT

+45 23715703 ple@clin.au.dk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.