Ammonia; Metabolic Disorder, Liver Failure, Chronic
Conditions
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.
Interventions
OTHERAmmonia infusion
Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)
Sponsors
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clearance (L/min) and production (micromol/min) of ammonia | 2 years | A physiological parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents | 2 years | Proof of concept |
Countries
Denmark
Contacts
Primary ContactPeter Lykke Eriksen, MD PhD
Outcome results
None listed