Dysregulated Urea-synthesis at Terminal Uremia

Not Applicable

Recruiting

• Conditions: Urea Cycle Disorder; Uremia
• Interventions: Other: Aminoacid, alanine-infusion

• Registration Number: NCT05076318
• Lead Sponsor: University of Aarhus

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-03-01
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Primary Completion: 2022-01-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alanine-infusion	Aminoacid, alanine-infusion	Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis

Primary Outcome Measures

Name	Time	Method
Urea synthesis rate during alanine infusion	4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion	Change in the synthesis of urea during a 3 hour period of alanine-infusion in pre and post hemodialysis patients. We will use a validated method named functional hepatic nitrogen clearance (FHNC) to evaluate the synthesis of urea. FHNC is calculated using the linear relation between urea nitrogen synthesis rate and blood-amino acid which is measured every hour. An estimated group of 10 dialysis patients will be included and compared to a clinical healthy group. The healthy group has also received alanine infusion and blood samples of urea and amino-acids has likewise been measured for every hour of infusion.

Trial Locations

Locations (1)

University Hospital Aarhus; 🇩🇰 Aarhus N, Denmark