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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN47228763 |
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Date of registration:
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24/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of different types of dialysis membranes on parameters of chronic inflammation
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Scientific title:
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Date of first enrolment:
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10/02/2005 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN47228763 |
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Study type:
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Interventional |
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Study design:
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Prospective, multicenter, randomised (Not Specified)
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Christian
Combe |
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Address:
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Hôpital Pellegrin
Service de Néphrologie
Place Amélie Raba-Léon
33076
Bordeaux
France |
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Telephone:
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Email:
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christian.combe@chu-bordeaux.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Medically stable end-stage renal disease patients on hemodialysis for 6 months or more
2. Age =18 years
3. C-reactive protein between 5 and 50 mg/l maximum one week before inclusion
4. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) serologies negative
5. Not under guardianship
6. AgHbs negative
7. Absence of vascular access thrombosis
8. Absence of clinically identifiable cause of chronic inflammation
9. Treatment in a dialysis unit providing water quality according to the European Pharmacopoeia
10. Statin medication allowed, but no introduction or modification during the study
11. Hemodialysis blood flow rates between 200 and 500 ml/min possible
12. Dialysis frequency 3-4 per week
Exclusion criteria: 1. Age >75 years
2. Known pregnancy
3. Severe comorbidities with life expectancy <1 year
4. Cancer except skin cancer
5. Severe digestive pathologies
6. Chronic inflammatory diseases
7. Medication interfering with nutritional or inflammatory status
8. Treatment or intention to treat with immunosuppressive medication
9. Dialysis dose Kt/V <1.2, and dialysis time <10 hours per week
10. Treatment with hemofiltration or hemodiafiltration
11. Participation in another study during the preceding 30 days
12. Physically or mentally disabled patients
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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End-stage renal disease
Urological and Genital Diseases
Renal disease
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Intervention(s)
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Hemodialysis treatment with high-flux versus low-flux dialysers of the same type of chemical composition
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Primary Outcome(s)
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Plasma concentration of C-reactive protein
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Secondary Outcome(s)
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Advanced glycation end products, carboxymethyl lysine, asymmetric dimethyl arginine, fibrinogen, albumin and prealbumin, phosphate
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Secondary ID(s)
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POL-FRA-1
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Source(s) of Monetary Support
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Gambro SAS
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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