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Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries

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. Identifier: NCT00764192
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 13, 2009
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University

Brief Summary:
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 or disease Intervention/treatment Phase
Hemodialysis Procedure: blood sample Procedure: Flow-mediated dilation (FMD) before and after a single HD Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
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
Study Start Date : October 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • known HD associated hypotension intake of nitrate

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 identifier (NCT number): NCT00764192

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University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Heinrich-Heine University, Duesseldorf
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Principal Investigator: Christian Meyer, MD RWTH Aachen University, Medical Clinic I
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christian Meyer, MD, RWTH Aachen University, Medical Clinic I, University Hospital Identifier: NCT00764192    
Other Study ID Numbers: EK DD 2022 CM
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009
Keywords provided by RWTH Aachen University:
Flow-mediated dilation
nictric oxide
endothelial function