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

This study is currently recruiting participants.

Verified January 2010 by Assistance Publique Hopitaux De Marseille

First Received on May 21, 2008. Last Updated on January 29, 2010 History of Changes

Sponsor:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00684034

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:	Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2012
Estimated 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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684034

Contacts

Contact: Bertrand DUSSOL, MD	49-138-3043	bdussol@ap-hm.fr
Contact: Philippe BRUNET, MD	49-138-3042	pbrunet@ap-hm.fr

Locations

France
Hopital de la Conception- Service de Néphrologie et de transplantation rénale	Recruiting
Marseille, France, 13385
Contact: Bertrand DUSSOL, MD 49-138-3043 bdussol@ap-hm.fr
Contact: Philippe BRUNET, MD 49-138-3042 pbrunet@ap-hm.fr

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Bertrand DUSSOL, MD

Assistance Publique des Hopitaux de Marseille

More Information

No publications provided

Responsible Party:	Assistance Publique des Hopitaux de Marseille
ClinicalTrials.gov Identifier:	NCT00684034 History of Changes
Other Study ID Numbers:	2007-A01179-44, 2007-38
Study First Received:	May 21, 2008
Last Updated:	January 29, 2010
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique Hopitaux De Marseille:

Redox state in the course of chronic renal insufficiency and hemodialysis.

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012