Dysregulated Urea-synthesis at Terminal Uremia

NCT05076318 | Completed

• 1 other identifier: Dysregulated urea-synthesis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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"

Conditions

Urea Cycle Disorder; Uremia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Alanine-infusion

EXPERIMENTAL

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

Other: Aminoacid, alanine-infusion

Interventions

Aminoacid, alanine-infusion OTHER

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

Alanine-infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

University Hospital Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn; Uremia

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: October 13, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 4, 2026

Record last verified: 2022-01

Locations

DK (1)