Ammonia Metabolism Assessed by Ammonia Infusion (NH4 inf)

October 12, 2020 updated by: Aarhus University Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Department of Hepatology & Gastroenterology
        • Contact:
          • Marie Fagerlund
          • Phone Number: +45 23715703
          • Email: mf@clin.au.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Healthy and Cirrhosis
Ammonia infusion with and without ammonia targeting
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clearance (L/min) and production (micromol/min) of ammonia
Time Frame: 2 years
A physiological parameter
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents
Time Frame: 2 years
Proof of concept
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 19, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (ACTUAL)

October 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-16-02-297-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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