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Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485706
First Posted: June 13, 2007
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universitaire Ziekenhuizen Leuven
  Purpose

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.


Condition Intervention
Kidney Disease Hypercalcemia Procedure: high calcium dialysate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • correlation between calcium increase and pulse wave velocity
  • correlation between calcium change and pth change

Secondary Outcome Measures:
  • correlation between calcium increase and vascular calcifications
  • correlation between calcium change and bone markers

Study Start Date: June 2007
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"

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • maintenance hemodialysis patients

Exclusion Criteria:

  • dialysis <3 months
  • aortobifemoral graft
  • calcium level predialysis >10.5 mg/dl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485706


Locations
Belgium
UZ Gasthuisberg
LEuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: kathleen Claes, MD UZ Gasthuisberg
  More Information

ClinicalTrials.gov Identifier: NCT00485706     History of Changes
Other Study ID Numbers: ML4181
S50455
First Submitted: June 12, 2007
First Posted: June 13, 2007
Last Update Posted: January 18, 2010
Last Verified: June 2007

Keywords provided by Universitaire Ziekenhuizen Leuven:
dialysis
vascular calcification
bone mineralism
arterial stiffness
bone metabolism
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Hypercalcemia
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Dialysis Solutions
Pharmaceutical Solutions