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Ammonia Metabolism Assessed by Ammonia Infusion (NH4 inf)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585672
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus ( 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.

Condition or disease Intervention/treatment Phase
Ammonia; Metabolic Disorder Liver Failure, Chronic Other: Ammonia infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ammonia Metabolism Assessed by Ammonia Infusion
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ammonia

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Rate of clearance (L/min) and production (micromol/min) of ammonia [ Time Frame: 2 years ]
    A physiological parameter


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585672


Contacts
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Contact: Peter Lykke Eriksen, MD PhD +45 23715703 ple@clin.au.dk

Locations
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Denmark
Department of Hepatology & Gastroenterology Recruiting
Aarhus, Denmark, 8200
Contact: Marie Fagerlund    +45 23715703    mf@clin.au.dk   
Sponsors and Collaborators
Aarhus University Hospital
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Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04585672    
Other Study ID Numbers: 1-16-02-297-20
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
End Stage Liver Disease
Metabolic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases