CLinical Evaluation of the AK-200 Ultra and oN-line HemoDiaFiltration with Bicarbonate Subsitution Fluid

ISRCTN	ISRCTN69849281
DOI	https://doi.org/10.1186/ISRCTN69849281
Secondary identifying numbers	N/A

Submission date: 26/05/2005
Registration date: 15/09/2005
Last edited: 14/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

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

Contact information

Dr Marc Dorval
Scientific

330 Université
Moncton
E1C 2Z3
Canada

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	CLEAN-HDF study
Study objectives	The CLEAN-HDF study is a randomized controlled trial comparing the performance of low-flux hemodialysis, high-flux hemodialysis and on-line hemodiafiltration with a cross over study design on a group of 48 ESRD patients using GAMBRO AK-200 Ultra generator. Research hypothesis are to demonstrate that mean % reduction of B2-microglobuline plasma concentration are superior in on-line hemodiafiltration compared to low- and high- flux hemodialysis and that the generator AK200 Ultra is capable of producing reliable sterile substitution fluid according to the European Pharmacopea
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Renal replacement therapy
Intervention	Randomised cross-over study of three hemodialysis modalities: low-flux haemodialysis, high-flux hemodialysis and on-line haemodiafiltration
Intervention type	Other
Primary outcome measure	1. Mean % reduction of B2-microglobuline plasma concentration during a mid-week session 2. Substitution fluid analysis (microbiology: culture and endotoxins and biochemical content)
Secondary outcome measures	A variety of exploratory outcomes: biochemical [for example Kt/V, total urea, creatinine of B2-microglobulin clearance, pre-post study change in b2-microglobulin concentrations, CRP, etc], dialysis tolerance, quality of life, nutritional parameters, etc).
Overall study start date	01/06/2005
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	48
Key inclusion criteria	Chronic end-staged renal diseased (ESRD) patients on haemodialysis
Key exclusion criteria	1. Hemodialysis for less than 3 months 2. Current or recent hospitalisation (less than 6 weeks) prior to screening period 3. Dysfunctional or infected vascular access 4. Intolerance to high-flux hemodialyser 5. Intolerance to multi-vitamin supplement 6. Severe co-morbidities limiting expected life expectance to less than 6 months 7. History of severe congestive heart failure (New York Heart Association [NYHA] class III and IV) 8. Uncontrolled hypertension (HTN) (systolic blood pressure [BP] over 200 or diastolic over 110) during the two week screening period 9. Significant and instable hypotension (systolic BP less than 90 or greater than 2 hypotension episodes/dialysis session for more than 3 sessions) during the two week screening period 10. Use of midodrine 11. Hepatite B, C or human immunodeficiency virus (HIV) positive serologies 12. Presence of pure red cell aplasia (PRCA) 13. Pregnancy or lactating 14. Current participation (or for less than 3 months) in another intervention trial 15. Presence of psychiatric, dependance or any other health problems that may compromise the hability of the subject to signed the informed consent form and/or affect compliance to the study
Date of first enrolment	01/06/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Canada

Study participating centre

330 Université

Moncton
E1C 2Z3
Canada

Sponsor information

Beauséjour Medical Research Institute (L'Institut de Recherche Médicale Beauséjour) (IRMB) (Canada)
Research organisation

37 Providence
Moncton
E1C 8X3
Canada

"ROR"	https://ror.org/029tnqt29

Funders

Funder type

Industry

Gambro (Canada)

No information available

Nephrology Department of the Beauséjour Regional Health Authority (Canada)

No information available

Results and Publications

Intention to publish date
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