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OpenTrials
Completed

NCT Number: NCT00485706

Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

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.

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Key information

Conditions

Kidney Disease Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypercalcemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Calcification Water-Electrolyte Imbalance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gasthuisberg

Leuven, 3000, Belgium

About this study

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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • maintenance hemodialysis patients

Exclusion criteria

  • dialysis <3 months
  • aortobifemoral graft
  • calcium level predialysis >10.5 mg/dl

Treatment and study plan

high calcium dialysate

Procedure

Primary outcomes

  1. correlation between calcium increase and pulse wave velocity

    correlation between calcium increase and pulse wave velocity

  2. correlation between calcium change and pth change

    correlation between calcium change and pth change

Secondary outcomes

  1. correlation between calcium increase and vascular calcifications

    correlation between calcium increase and vascular calcifications

  2. correlation between calcium change and bone markers

    correlation between calcium change and bone markers

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2007
First posted
Jun 13, 2007
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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