Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000577910
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
6/06/2011
Date last updated
6/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of hemodialysis, hemodiafiltration and peritoneal dialysis on asymmetric dimethylarginine and markers of oxidative stress
Scientific title
Influence of hemodialysis, hemodiafiltration and peritoneal dialysis on asymmetric dimethylarginine and markers of oxidative stress in patients with chronic renal failure.
Secondary ID [1] 1011 0
CRG030600046
Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal disease 243727 0
Condition category
Condition code
Metabolic and Endocrine 256700 256700 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight weeks of hemodialysis (HD, low-flux polysulfone membrane) versus eight weeks of on-line predilution hemodiafiltration (HDF, high-flux polysulfone membrane, susbstitution volume 200 mL/min)), duration of both HD and HDF was 4.5 hrs/session 3 times a week. Crossover study, 1 week break in between.
Intervention code [1] 255807 0
Treatment: Devices
Comparator / control treatment
Controls were volunteers without renal disease and without treatment. We studied baseline values of controls, 20 HD patients and 19 peritoenal dialysis patients. Then, randomly selected 16 HD patients were randomized to crossover study, 8 started with HD, 8 with HDF.
Control group
Active

Outcomes
Primary outcome [1] 240795 0
Change in plasma levels of asymmetric dimethylarginine (ADMA), advanced glycation end-products and homocystein after a period of 8 weeks of hemodiafiltration or hemodialysis. This primary outcome is being done in patients with end stage renal disease.
Timepoint [1] 240795 0
after 8 weeks of treatment
Secondary outcome [1] 276575 0
Nil
Timepoint [1] 276575 0
Nil

Eligibility
Key inclusion criteria
Patients: persons on maintenance hemodialysis or peritoneal dialysis for at least 3 months. Controls: healthy volunteers withou renal disease.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable clinical condition, infection, malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trial subjects for HD and HDF were randomised using simple randomisation (random numbers table)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2048 0
Czech Republic
State/province [1] 2048 0

Funding & Sponsors
Funding source category [1] 256292 0
Government body
Name [1] 256292 0
Research Project No. MSM 0021620819, Ministry of Health, Czech Republic.
Country [1] 256292 0
Czech Republic
Primary sponsor type
Government body
Name
Research Project No. MSM 0021620819, Ministry of Health, Czech Republic.
Address
Ministry of Health,
Palackeho square 4
128 01 Praha 2
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 251618 0
None
Name [1] 251618 0
Address [1] 251618 0
Country [1] 251618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258384 0
Ethics Commitee
Ethics committee address [1] 258384 0
Medical School and Teaching Hospital Plzen
13 dr. E. Benese
301 00 Plzen
Czech Republic
Ethics committee country [1] 258384 0
Czech Republic
Date submitted for ethics approval [1] 258384 0
26/01/2006
Approval date [1] 258384 0
26/02/2006
Ethics approval number [1] 258384 0

Summary
Brief summary
Increased ADMA levels in patients undergoing HD, as compared to PD, may be caused by higher oxidative stress and lower residual renal function in HD. Other
factors, such as diabetes and statin therapy, may also be at play. The decrease in ADMA at the end of HD and HDF
is comparable. Switching from HD to HDF decreases in 8 weeks the predialysis levels of homocysteine without affecting ADMA.
Trial website
Trial related presentations / publications
Published in Artif Organs. 2010 May;34(5):420-5.
Asymmetric dimethylarginine in hemodialysis, hemodiafiltration, and peritoneal dialysis.
Eiselt J, Rajdl D, Racek J, Siroká R, Trefil L, Opatrná S.
Public notes

Contacts
Principal investigator
Name 30180 0
Address 30180 0
Country 30180 0
Phone 30180 0
Fax 30180 0
Email 30180 0
Contact person for public queries
Name 13427 0
Dr, Jaromir, Eiselt
Address 13427 0
Lecturer, Department of Internal Medicine I, Charles University, School of Medicine, Alej Svobody 80, 304 60, Plzen, Czech Republic
Country 13427 0
Czech Republic
Phone 13427 0
+420 377 103 925
Fax 13427 0
+420 377 103 920
Email 13427 0
[email protected]
Contact person for scientific queries
Name 4355 0
Dr, Jaromir, Eiselt
Address 4355 0
Lecturer, Department of Internal Medicine I, Charles University, School of Medicine, Alej Svobody 80, 304 60, Plzen, Czech Republic
Country 4355 0
Czech Republic
Phone 4355 0
+420 377 103 925
Fax 4355 0
+420 377 103 920
Email 4355 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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