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Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431314
First Posted: February 5, 2007
Last Update Posted: July 9, 2008
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.
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Isala
  Purpose

The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence.

Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.


Condition
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Hemodialysis on Toe Pressure- and Finger Pressure Measurements and Measurement of Skin Autofluorescence; a Pilot Study in the Assessment of Critical Limb Ischemia in Hemodialysis Patients.

Resource links provided by NLM:


Further study details as provided by Isala:

Enrollment: 82
Study Start Date: January 2007
Study Completion Date: March 2007
Detailed Description:
  1. To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
  2. Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
  3. To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not.
  4. To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hemodialysis patients in one hemodialysis centre
Criteria

Inclusion Criteria:

  • Patients with End Stage Renal Disease with hemodialysis therapy

Exclusion Criteria:

  • Hemodialysis during the night
  • Dark coloured skin towards unreliable skin autofluorescence measurements
  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): NCT00431314


Sponsors and Collaborators
Isala
Dutch Diabetes Research Foundation
Investigators
Study Director: Henk J Bilo, PhD Center of Excellence Diabetes
  More Information

Responsible Party: Dutch research foundation
ClinicalTrials.gov Identifier: NCT00431314     History of Changes
Other Study ID Numbers: HD
First Submitted: February 2, 2007
First Posted: February 5, 2007
Last Update Posted: July 9, 2008
Last Verified: January 2007

Keywords provided by Isala:
End Stage Renal Disease
Hemodialysis
Critical Limb Ischemia
Autofluorescence

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency