NCT00684034

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

3.8 years

First QC Date

May 21, 2008

Last Update Submit

August 27, 2014

Conditions

Keywords

Redox state in the course of chronic renal insufficiency and hemodialysis.

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

OTHER

Volunteer healthy

Other: Sampling of blood

2

OTHER

Patient dialysis patient

Other: Sampling of blood

3

OTHER

Not dialysed chronic renal insufficient patient

Other: Sampling of blood

Interventions

A sampling of blood will be made

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bertrand DUSSOL, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

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

Locations