Ammonia Metabolism Assessed by Ammonia Infusion | NCT04585672

Studies
Ammonia Metabolism Assessed by Ammonia Infusion

NCT04585672

Sponsor

Aarhus University Hospital

Status

Unknown status

Last Update Posted

Oct 14, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Ammonia; Metabolic Disorder
Liver Failure, Chronic

Interventions

Ammonia infusion

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Sep 23, 2020

First Submission Date that Met QC Criteria

Oct 12, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy and Cirrhosis	Other	Ammonia infusion with and without ammonia targeting	Other: Ammonia infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ammonia infusion	Other	Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Lykke Eriksen, MD PhD	Contact	+45 23715703		ple@clin.au.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatology & Gastroenterology	Recruiting	Aarhus		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases
D058625	End Stage Liver Disease

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided