Back to resultsAmmonia Metabolism Assessed by Ammonia Infusion (NH4 inf)
Primary Purpose
Ammonia; Metabolic Disorder, Liver Failure, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ammonia infusion
Sponsored by
About this trial
This is an interventional other trial for Ammonia; Metabolic Disorder
Eligibility 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)
Sites / Locations
- Department of Hepatology & GastroenterologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthy and Cirrhosis
Arm Description
Ammonia infusion with and without ammonia targeting
Outcomes
Primary Outcome Measures
Rate of clearance (L/min) and production (micromol/min) of ammonia
A physiological parameter
Secondary Outcome Measures
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents
Proof of concept
Full Information
NCT ID
NCT04585672
First Posted
September 23, 2020
Last Updated
October 12, 2020
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04585672
Brief Title
Ammonia Metabolism Assessed by Ammonia Infusion
Acronym
NH4 inf
Official Title
Ammonia Metabolism Assessed by Ammonia Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ammonia; Metabolic Disorder, Liver Failure, Chronic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy and Cirrhosis
Arm Type
Other
Arm Description
Ammonia infusion with and without ammonia targeting
Intervention Type
Other
Intervention Name(s)
Ammonia infusion
Intervention Description
Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)
Primary Outcome Measure Information:
Title
Rate of clearance (L/min) and production (micromol/min) of ammonia
Description
A physiological parameter
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents
Description
Proof of concept
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Lykke Eriksen, MD PhD
Phone
+45 23715703
Email
ple@clin.au.dk
Facility Information:
Facility Name
Department of Hepatology & Gastroenterology
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Fagerlund
Phone
+45 23715703
Email
mf@clin.au.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ammonia Metabolism Assessed by Ammonia Infusion
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