Ammonia Metabolism Assessed by Ammonia Infusion

NCT ID: NCT04585672

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ammonia; Metabolic Disorder Liver Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy and Cirrhosis

Ammonia infusion with and without ammonia targeting

Group Type OTHER

Ammonia infusion

Intervention Type OTHER

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

Interventions

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Ammonia infusion

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Alcohol \< 40g/day
* BMI \< 30
* Diseased or medicated


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Hepatology & Gastroenterology

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Peter Lykke Eriksen, MD PhD

Role: CONTACT

+45 23715703

Facility Contacts

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Marie Fagerlund

Role: primary

+45 23715703

Other Identifiers

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1-16-02-297-20

Identifier Type: -

Identifier Source: org_study_id

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