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Dysregulated Urea-synthesis at Terminal Uremia

Dysregulated Urea-synthesis at Terminal Uremia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05076318
Enrollment
10
Registered
2021-10-13
Start date
2022-03-01
Completion date
2024-12-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urea Cycle Disorder, Uremia

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"

Interventions

OTHERAminoacid, alanine-infusion

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urea synthesis rate during alanine infusion4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusionChange 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026