NCT00764192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

September 26, 2008

Last Update Submit

January 12, 2009

Conditions

Hemodialysis

Keywords

hemodialysisFlow-mediated dilationnictric oxideendothelial function

Outcome Measures

Primary Outcomes (1)

  • influence of hemodialysis on endothelial function as determined by plasma nitrite concentration

    before and after hemodialysis

Secondary Outcomes (1)

  • influence on hemodialysis on endothelial function as determined by measurement of flow-mediated dilation (FMD) of teh brachial artery using high resolution ultrasound

    before and after hemodialysis

Study Arms (1)

1

EXPERIMENTAL

14 HD patients are studied before and after a single HD using a polysulphone dialyser.

Procedure: blood sampleProcedure: Flow-mediated dilation (FMD) before and after a single HD

Interventions

blood samplePROCEDURE

blood sample before and after a single HD

Also known as: biochemistry
1
Flow-mediated dilation (FMD) before and after a single HDPROCEDURE

measuring of the flow-mediated dilation using high-resolution ultrasound

Also known as: endothelial function
1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • known HD associated hypotension intake of nitrate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • Meyer C, Heiss C, Drexhage C, Kehmeier ES, Balzer J, Muhlfeld A, Merx MW, Lauer T, Kuhl H, Floege J, Kelm M, Rassaf T. Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function. J Am Coll Cardiol. 2010 Feb 2;55(5):454-9. doi: 10.1016/j.jacc.2009.07.068.

    PMID: 20117459DERIVED

MeSH Terms

Interventions

Blood Specimen CollectionLead

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Christian Meyer, MD

    RWTH Aachen University, Medical Clinic I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2008

First Posted

October 1, 2008

Study Start

October 1, 2006

Primary Completion

February 1, 2007

Study Completion

October 1, 2007

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations

DE(1)