NCT04585672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

September 23, 2020

Last Update Submit

October 12, 2020

Conditions

Ammonia; Metabolic DisorderLiver Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Rate of clearance (L/min) and production (micromol/min) of ammonia

    A physiological parameter

    2 years

Secondary Outcomes (1)

  • Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents

    2 years

Study Arms (1)

Healthy and Cirrhosis

OTHER

Ammonia infusion with and without ammonia targeting

Other: Ammonia infusion

Interventions

Ammonia infusionOTHER

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

Healthy and Cirrhosis

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcohol \< 40g/day
  • BMI \< 30
  • Diseased or medicated
  • Child-Pugh A or B cirrhosis
  • BMI \< 30

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology & Gastroenterology

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Metabolic DiseasesEnd Stage Liver Disease

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Peter Lykke Eriksen, MD PhD

CONTACT

+45 23715703ple@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 14, 2020

Study Start

August 19, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)