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

Not Applicable

Completed

• Conditions: Chronic Renal Insufficiency
• Interventions: Other: Sampling of blood

• Registration Number: NCT00684034
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Study Start: 2008-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sampling of blood	Patient dialysis patient
1	Sampling of blood	Volunteer healthy
3	Sampling of blood	Not dialysed chronic renal insufficient patient

Primary Outcome Measures

Name	Time	Method
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.	48 months

Secondary Outcome Measures

Name	Time	Method
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.	48 months

Trial Locations

Locations (1)

Hopital de la Conception- Service de Néphrologie et de transplantation rénale; 🇫🇷 Marseille, France