Glucose in Dialysis Water in Non-diabetics
Primary Purpose
Renal Failure, Chronic
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
dialysis with glucose in dialysis water
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure, Chronic focused on measuring Chronic renal failure, dialysis, hemodialysis,
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years,
- Both men and women,
- Dialysis treatment for at least three months
Exclusion Criteria:
- Heart failure,
- Chronic liver disease,
- Diabetes mellitus,
- Malignant disease,
- Nephrotic syndrome,
- Lack of compliance, 7 Unwillingness to participate
Sites / Locations
- Holstebro Hospital
Outcomes
Primary Outcome Measures
Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones
Secondary Outcome Measures
Relationship between changes in blood pressure and changes in hormones during treatment
Full Information
NCT ID
NCT00439023
First Posted
February 20, 2007
Last Updated
September 14, 2015
Sponsor
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT00439023
Brief Title
Glucose in Dialysis Water in Non-diabetics
Official Title
Effect of Glucose in Dialysis Water on Blood Pressure and Vasoactive Hormones in Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Regional Hospital Holstebro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purposes are
to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and
to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other
Detailed Description
Measurement of hormones and blood pressure during dialysis treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic
Keywords
Chronic renal failure, dialysis, hemodialysis,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
dialysis with glucose in dialysis water
Primary Outcome Measure Information:
Title
Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones
Time Frame
one week
Secondary Outcome Measure Information:
Title
Relationship between changes in blood pressure and changes in hormones during treatment
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years,
Both men and women,
Dialysis treatment for at least three months
Exclusion Criteria:
Heart failure,
Chronic liver disease,
Diabetes mellitus,
Malignant disease,
Nephrotic syndrome,
Lack of compliance, 7 Unwillingness to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, Professor
Organizational Affiliation
Regional Hospital Holstebro
Official's Role
Study Chair
Facility Information:
Facility Name
Holstebro Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Glucose in Dialysis Water in Non-diabetics
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