Influence of different types of dialysis membranes on parameters of chronic inflammation

ISRCTN	ISRCTN47228763
DOI	https://doi.org/10.1186/ISRCTN47228763
Secondary identifying numbers	POL-FRA-1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Christian Combe
Scientific

Hôpital Pellegrin
Service de Néphrologie
Place Amélie Raba-Léon
Bordeaux
33076
France

Email	christian.combe@chu-bordeaux.fr

Study design	Prospective, multicenter, randomised
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	INFLUX
Study objectives	The aim of the study is to evaluate the influence of dialysis membrane permeability on biological parameters that predict morbidity and mortality of hemodialysis patients with moderate chronic inflammation
Ethics approval(s)	Consulting committee for the protection of people in biomedical research, Bordeaux A (Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale [CCPPRB] de Bordeaux A) - number 2004/49, June 18, 2004.
Health condition(s) or problem(s) studied	End-stage renal disease
Intervention	Hemodialysis treatment with high-flux versus low-flux dialysers of the same type of chemical composition
Intervention type	Other
Primary outcome measure	Plasma concentration of C-reactive protein
Secondary outcome measures	Advanced glycation end products, carboxymethyl lysine, asymmetric dimethyl arginine, fibrinogen, albumin and prealbumin, phosphate
Overall study start date	10/02/2005
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	180
Key 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
Key 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
Date of first enrolment	10/02/2005
Date of final enrolment	31/12/2006

Hôpital Pellegrin

Bordeaux
33076
France

Gambro SAS (France)
Industry

1-3, Boulevard Charles-de-Gaulle
Colombes
92707
France

Email	georges.martin@gambro.com
"ROR"	https://ror.org/01mgtdr23

Industry

Gambro SAS

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Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan