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Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00485706
First received: June 12, 2007
Last updated: January 15, 2010
Last verified: June 2007
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485706

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

No publications provided

ClinicalTrials.gov Identifier: NCT00485706     History of Changes
Other Study ID Numbers: ML4181, S50455
Study First Received: June 12, 2007
Last Updated: January 15, 2010
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013