Back to resultsDysregulated Urea-synthesis at Terminal Uremia
Primary Purpose
Urea Cycle Disorder, Uremia
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Aminoacid, alanine-infusion
Sponsored by
About this trial
This is an interventional treatment trial for Urea Cycle Disorder
Eligibility Criteria
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
Sites / Locations
- University Hospital AarhusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alanine-infusion
Arm Description
Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05076318
Brief Title
Dysregulated Urea-synthesis at Terminal Uremia
Official Title
Dysregulated Urea-synthesis at Terminal Uremia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urea Cycle Disorder, Uremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alanine-infusion
Arm Type
Experimental
Arm Description
Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis
Intervention Type
Other
Intervention Name(s)
Aminoacid, alanine-infusion
Intervention Description
During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.
Primary Outcome Measure Information:
Title
Urea synthesis rate during alanine infusion
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasmus Eriksen, MD
Phone
30264691
Email
rasmus.s.eriksen@hotmail.com
Facility Information:
Facility Name
University Hospital Aarhus
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus Eriksen, MD
Phone
30264691
Email
raerik@rm.dk
12. IPD Sharing Statement
Learn more about this trial
Dysregulated Urea-synthesis at Terminal Uremia
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