Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients - Full Text View

Sponsor:	Universitaire Ziekenhuizen Leuven
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00485706

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:	Control: Uncontrolled 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:

MedlinePlus related topics: Calcium Dialysis Kidney Failure

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

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

Calcium Metabolism Disorders
Metabolic Diseases
Urologic Diseases

Hypercalcemia
Water-Electrolyte Imbalance
Kidney Diseases

ClinicalTrials.gov processed this record on March 18, 2010