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Interactive Studies of Endstage Diabetic Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00175734
Recruitment Status : Unknown
Verified January 2013 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.

Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.


Condition or disease Intervention/treatment
Diabetes Procedure: High Hemoglobin Concentration Procedure: Low Hemoglobin Concentration

Detailed Description:

Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.

Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.

Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients
Study Start Date : August 2005
Primary Completion Date : December 2007
Estimated Study Completion Date : December 2013
Arms and Interventions

Intervention Details:
    Procedure: High Hemoglobin Concentration
    The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
    Procedure: Low Hemoglobin Concentration
    The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.

Outcome Measures

Primary Outcome Measures :
  1. To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test [ Time Frame: 8-12 months per participant ]

Secondary Outcome Measures :
  1. Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires [ Time Frame: 8-12 months per participant ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Diabetics and non-diabetics on hemodialysis
  • On erythropoietin and iron
  • On a statin

Exclusion Criteria:

  • Uncontrolled blood pressure (BP)
  • Ulcers
  • Amputations
  • Unstable cardiac function
  • Malignancy
  • Planned operations
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): NCT00175734


Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Adeera Levin University of British Columbia
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175734     History of Changes
Other Study ID Numbers: P04-0007
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by University of British Columbia:
Vascular Reactivity
Anemia Correction Therapy
Hemodialysis patients
Diabetic and non-diabetic patients
Diabetes in Hemodialysis patients