Dysregulated Urea-synthesis at Terminal Uremia

NCT ID: NCT05076318

Last Updated: 2021-10-13

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-12-01

Brief Summary

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This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"

Detailed Description

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Conditions

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Urea Cycle Disorder Uremia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alanine-infusion

Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis

Group Type EXPERIMENTAL

Aminoacid, alanine-infusion

Intervention Type OTHER

During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.

Interventions

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Aminoacid, alanine-infusion

During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> or equal to 18 years
* Chronic hemodialysis during 3 months
* Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"

Exclusion Criteria

* Active infection
* Conditions with vomiting or diarrhea
* Diabetes
* Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.
* Liver disease
* Vessels on the upper extremities not suited for cannulation
* Prednisolone treatment during the last 8 weeks
* Pregnancy
* BMI \> or equal to 30 or \< or equal to 18
* Physically or mentally condition that does not allow the project to be completed
* Language-difficulties that does not allow the project to be completed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Aarhus

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Rasmus Eriksen, MD

Role: CONTACT

Facility Contacts

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Rasmus Eriksen, MD

Role: primary

Other Identifiers

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Dysregulated urea-synthesis

Identifier Type: -

Identifier Source: org_study_id