Dysregulated Urea-synthesis at Terminal Uremia

Uremia Clinical Trial

Official title:

Dysregulated Urea-synthesis at Terminal Uremia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076318
• Other study ID #: Dysregulated urea-synthesis
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2021
• Source: University of Aarhus
• Contact: Rasmus Eriksen, MD
• Phone: 30264691
• Email: rasmus.s.eriksen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urea Cycle Disorder
• Urea Cycle Disorders, Inborn
• Uremia

Intervention

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

Locations

Country	Name	City	State
Denmark	University Hospital Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion