Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Primary Purpose
Kidney Disease, Hypercalcemia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
high calcium dialysate
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Disease focused on measuring dialysis, vascular calcification, bone mineralism, arterial stiffness, bone metabolism, chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- maintenance hemodialysis patients
Exclusion Criteria:
- dialysis <3 months
- aortobifemoral graft
- calcium level predialysis >10.5 mg/dl
Sites / Locations
- UZ Gasthuisberg
Outcomes
Primary Outcome Measures
correlation between calcium increase and pulse wave velocity
correlation between calcium increase and pulse wave velocity
correlation between calcium change and pth change
correlation between calcium change and pth change
Secondary Outcome Measures
correlation between calcium increase and vascular calcifications
correlation between calcium increase and vascular calcifications
correlation between calcium change and bone markers
correlation between calcium change and bone markers
Full Information
NCT ID
NCT00485706
First Posted
June 12, 2007
Last Updated
October 15, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT00485706
Brief Title
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Official Title
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.
In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.
Detailed Description
Study hypothesis.
Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.
This may result in higher extraosseous calcification and higher pulse wave velocity
∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Hypercalcemia
Keywords
dialysis, vascular calcification, bone mineralism, arterial stiffness, bone metabolism, chronic kidney disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high calcium dialysate
Primary Outcome Measure Information:
Title
correlation between calcium increase and pulse wave velocity
Description
correlation between calcium increase and pulse wave velocity
Title
correlation between calcium change and pth change
Description
correlation between calcium change and pth change
Secondary Outcome Measure Information:
Title
correlation between calcium increase and vascular calcifications
Description
correlation between calcium increase and vascular calcifications
Title
correlation between calcium change and bone markers
Description
correlation between calcium change and bone markers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
maintenance hemodialysis patients
Exclusion Criteria:
dialysis <3 months
aortobifemoral graft
calcium level predialysis >10.5 mg/dl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kathleen Claes, MD
Organizational Affiliation
UZ Gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Gasthuisberg
City
LEuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
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