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

Genetics Home Reference related topics:   Kidney Diseases  

MedlinePlus related topics:   Dialysis   Kidney Failure  

ChemIDplus related topics:   Calcium gluconate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title:   Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

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 %u2206 Calcium (Calcium post %u2013 Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller %u2206 Calcium.

This may result in higher extraosseous calcification and higher pulse wave velocity

%u2206 PTH/%u2206 Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid %u201Chealth%u201D

  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

Contacts
Contact: Kathleen Claes, MD     3216344580     kathleen.claes@uz.kuleuven.ac.be    
Contact: Pieter Evenepoel, MD, PhD     3216344580     pieter.evenepoel@uz.kuleuven.ac.be    

Locations
Belgium
UZ Gasthuisberg     Recruiting
      LEuven, Belgium, 3000

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Investigators
Principal Investigator:     kathleen Claes, MD     UZ Gasthuisberg    
Contact: Kathleen Claes, MD     3216344580     kathleen.claes@uz.kuleuven.ac.be    
Contact: Pieter Evenepoel, MD, PhD     3216344580     pieter.evenepoel@uz.kuleuven.ac.be    
Belgium
UZ Gasthuisberg     Recruiting
      LEuven, Belgium, 3000
Universitaire Ziekenhuizen Leuven
Principal Investigator:     kathleen Claes, MD     UZ Gasthuisberg    
  More Information

Study ID Numbers:   ML4181, S50455
First Received:   June 12, 2007
Last Updated:   June 12, 2007
ClinicalTrials.gov Identifier:   NCT00485706
Health Authority:   Belgium : ethics committee

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

Study placed in the following topic categories:
Metabolic Diseases
Urologic Diseases
Hypercalcemia
Kidney Failure, Chronic
Water-Electrolyte Imbalance
Kidney Diseases
Metabolic disorder

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Hypercalcemia

Source: National Library of Medicine (NLM) July 07, 2008