Dysregulated Urea-synthesis at Terminal Uremia

University of Aarhus

Status: Enrolling

Conditions: Urea Cycle Disorder; Uremia

Treatments: Other: Aminoacid, alanine-infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05076318

Dysregulated urea-synthesis

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Alanine-infusion

Experimental group

Description:

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

Treatment:

Other: Aminoacid, alanine-infusion