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Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764192
First Posted: October 1, 2008
Last Update Posted: January 13, 2009
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:
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University
  Purpose
An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD.

Condition Intervention
Hemodialysis Procedure: blood sample Procedure: Flow-mediated dilation (FMD) before and after a single HD

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Angiologic Study of the Influence of Hemodialysis on Endothelial Function

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • influence of hemodialysis on endothelial function as determined by plasma nitrite concentration [ Time Frame: before and after hemodialysis ]

Secondary Outcome Measures:
  • influence on hemodialysis on endothelial function as determined by measurement of flow-mediated dilation (FMD) of teh brachial artery using high resolution ultrasound [ Time Frame: before and after hemodialysis ]

Enrollment: 14
Study Start Date: October 2006
Study Completion Date: October 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
14 HD patients are studied before and after a single HD using a polysulphone dialyser.
Procedure: blood sample
blood sample before and after a single HD
Other Name: biochemistry
Procedure: Flow-mediated dilation (FMD) before and after a single HD
measuring of the flow-mediated dilation using high-resolution ultrasound
Other Name: endothelial function

Detailed Description:
Cardiovascular complications are the major cause of death in end-stage renal disease (ESRD) patients undergoing chronic haemodialysis (HD).1 During haemodialysis (HD) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 Adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (NO) bioactivity and enhanced formation of oxygen-derived free radicals.7 Given that endothelial dysfunction is at least in part reversible, the assessment of altered NO availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in HD.8 Nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 The rates of NO consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will NO produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 However, the rate of NO scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 This mechanism is believed to be important in various conditions of health and disease.14-16 In ESRD intravascular hemolysis during HD has been described.17-19
  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients older 21 years dependent on HD for more than 6 months

Exclusion Criteria:

  • known HD associated hypotension intake of nitrate
  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): NCT00764192


Locations
Germany
University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Christian Meyer, MD RWTH Aachen University, Medical Clinic I
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Meyer, MD, RWTH Aachen University, Medical Clinic I, University Hospital
ClinicalTrials.gov Identifier: NCT00764192     History of Changes
Other Study ID Numbers: EK DD 2022 CM
First Submitted: September 26, 2008
First Posted: October 1, 2008
Last Update Posted: January 13, 2009
Last Verified: January 2009

Keywords provided by RWTH Aachen University:
hemodialysis
Flow-mediated dilation
nictric oxide
endothelial function