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

August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13385
        • Hopital de la Conception- Service de Néphrologie et de transplantation rénale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Volunteer healthy
Other: Sampling of blood
A sampling of blood will be made
Other: Sampling of blood
A sampling of bood will be made before the dialysis
Other: Sampling of blood
A sampling of blood will be made.
OTHER: 2
Patient dialysis patient
Other: Sampling of blood
A sampling of blood will be made
Other: Sampling of blood
A sampling of bood will be made before the dialysis
Other: Sampling of blood
A sampling of blood will be made.
OTHER: 3
Not dialysed chronic renal insufficient patient
Other: Sampling of blood
A sampling of blood will be made
Other: Sampling of blood
A sampling of bood will be made before the dialysis
Other: Sampling of blood
A sampling of blood will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Bertrand DUSSOL, MD, Assistance Publique des Hôpitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-A01179-44
  • 2007-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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