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Dysregulated Urea-synthesis at Terminal Uremia

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076318
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
45
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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"

Condition or Disease Intervention/Treatment Phase
  • Other: Aminoacid, alanine-infusion
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dysregulated Urea-synthesis at Terminal Uremia
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alanine-infusion

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Aarhus Aarhus N Denmark 8200

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05076318
Other Study ID Numbers:
  • Dysregulated urea-synthesis
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urea Cycle Disorders, Inborn
Uremia

Study Results

No Results Posted as of Oct 13, 2021