Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00684034
First received: May 21, 2008
Last updated: January 29, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 May 23, 2013