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

This study has been completed.
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Isala Klinieken
ClinicalTrials.gov Identifier:
NCT00431314
First received: February 2, 2007
Last updated: July 8, 2008
Last verified: January 2007
  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 Klinieken:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431314

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

No publications provided

Responsible Party: Dutch research foundation, -
ClinicalTrials.gov Identifier: NCT00431314     History of Changes
Other Study ID Numbers: HD
Study First Received: February 2, 2007
Last Updated: July 8, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on October 21, 2014