Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries

This study has been completed.
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00764192
First received: September 26, 2008
Last updated: January 12, 2009
Last verified: January 2009
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by RWTH Aachen University

Additional 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
Study First Received: September 26, 2008
Last Updated: January 12, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 28, 2014