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Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684034
First Posted: May 26, 2008
Last Update Posted: August 28, 2014
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.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose
The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.

Condition Intervention
Chronic Renal Insufficiency Other: Sampling of blood

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • This study should allow to clarify the redox state some plasma by quantification of thiols membranous on the surface of lymphocytes at the hemodialysis and insufficient renal chronic not dialysed patients. [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • This study should allow to estimate in a forward-looking longitudinal plan the possible involvement of the parameters of the redox state and the morbidity and the cardiovascular and global mortality in 2 years in 2 studied populations. [ Time Frame: 48 months ]

Enrollment: 131
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Volunteer healthy
Other: Sampling of blood
A sampling of blood will be made
2
Patient dialysis patient
Other: Sampling of blood
A sampling of bood will be made before the dialysis
3
Not dialysed chronic renal insufficient patient
Other: Sampling of blood
A sampling of blood will be made.

Detailed Description:
Up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients with Kidney Failure. Thus it is necessary to have a better knowledge of oxydative stress mechanisms in patients with KF in order to find more efficacious treatments. The influence of hemodialysis upon oxidative stress is not well known.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 and 80 years old man or woman dialysing at least 3 times a week for at least 6 months and having no residual renal function
  • Rate of haemoglobin > 11 g / dl
  • Clinically stable patient that is having had no considerable event (cardiovascular problem, infection, surgical operation) with the exception of angioplasty of fistula or prosthesis vascular, in the previous 3 months the entrance to the study
  • Patient capable of understanding and of following the essay, in particular knowing how to read the note of information.

Exclusion Criteria:

  • Pregnant woman
  • Treatment by corticoids or immunosuppresseurs
  • hemopathy sly
  • chronic cancer or infection in evolution
  • Cardiovascular event (infarct, unstable angor, coronary bypasses, confusions of the rhythm, AVC, amputation) or infectious (blood-poisoning, pneumopathie, meningitis) or surgical operation in the previous 3 months the inclusion in the study.
  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): NCT00684034


Locations
France
Hopital de la Conception- Service de Néphrologie et de transplantation rénale
Marseille, France, 13385
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Bertrand DUSSOL, MD Assistance Publique des Hopitaux de Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00684034     History of Changes
Other Study ID Numbers: 2007-A01179-44
2007-38
First Submitted: May 21, 2008
First Posted: May 26, 2008
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
Redox state in the course of chronic renal insufficiency and hemodialysis.

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases