Dysregulated Urea-synthesis at Terminal Uremia

October 12, 2021 updated by: University of Aarhus
This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • University Hospital Aarhus
        • Contact:
          • Rasmus Eriksen, MD
          • Phone Number: 30264691
          • Email: raerik@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urea synthesis rate during alanine infusion
Time Frame: 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.
4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dysregulated urea-synthesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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