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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00684034
• Date of registration: 21/05/2008
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique Hopitaux De Marseille
• Public title: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
• Scientific title: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
• Date of first enrolment: June 2008
• Target sample size: 131
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00684034
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bertrand DUSSOL, MD
• Affiliation: Assistance Publique des Hopitaux de Marseille

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Renal Insufficiency

Intervention(s)

Other: Sampling of blood

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

2007-A01179-44

2007-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors