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NCT00485706 Clinical Trial

Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

Kidney Disease Clinical Trial

Official title:
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00485706
Other study ID # ML4181
Secondary ID S50455
Status Completed
Phase N/A
First received
Last updated
Start date June 2007

Study information
Verified date October 2018
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- maintenance hemodialysis patients

Exclusion Criteria:

- dialysis <3 months

- aortobifemoral graft

- calcium level predialysis >10.5 mg/dl

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• high calcium dialysate

Locations
Country Name City State
Belgium UZ Gasthuisberg LEuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation between calcium increase and pulse wave velocity correlation between calcium increase and pulse wave velocity
Primary correlation between calcium change and pth change correlation between calcium change and pth change
Secondary correlation between calcium increase and vascular calcifications correlation between calcium increase and vascular calcifications
Secondary correlation between calcium change and bone markers correlation between calcium change and bone markers
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