Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
2 other identifiers
interventional
131
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 28, 2014
August 1, 2014
3.8 years
May 21, 2008
August 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
1
OTHERVolunteer healthy
2
OTHERPatient dialysis patient
3
OTHERNot dialysed chronic renal insufficient patient
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant woman
- Treatment by corticoids or immunosuppresseurs
- hemopathy sly
- chronic cancer or infection in evolution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital de la Conception- Service de Néphrologie et de transplantation rénale
Marseille, 13385, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertrand DUSSOL, MD
Assistance Publique des Hopitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 26, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 28, 2014
Record last verified: 2014-08