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

This study has been completed.

First Received: February 2, 2007 Last Updated: July 8, 2008 History of Changes

Sponsors and Collaborators:	Isala Klinieken Dutch Diabetes Research Foundation
Information provided by:	Isala Klinieken
ClinicalTrials.gov Identifier:	NCT00431314

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

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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.

Further study details as provided by Isala Klinieken:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	82
Study Start Date:	January 2007
Study Completion Date:	March 2007

Detailed Description:

To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
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.
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

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

Keywords provided by Isala Klinieken:

Autofluorescence
Critical Limb Ischemia
End Stage Renal Disease
Hemodialysis

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Ischemia
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on March 16, 2009