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

Chronic Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684034
• Other study ID #: 2007-A01179-44
• Secondary ID: 2007-38
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: August 27, 2014
• Start date: June 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Sampling of blood
A sampling of blood will be made
• Sampling of blood
A sampling of bood will be made before the dialysis
• Sampling of blood
A sampling of blood will be made.

Locations

Country	Name	City	State
France	Hopital de la Conception- Service de Néphrologie et de transplantation rénale	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes