Randomized clinical trial of comparing hemodialysis with high-flux and low-flux filters in controlling hyperphosphatemia in patients with end stage renal disease
(1) Objectives: Our aim in this study is to compare the effects of using high-flux and low-flux dialysis on controlling hyperphosphatemia in patients with end stage renal disease. (2) Design: Sixty patients under dialysis from both genders will be included in a double blind randomized clinical trial. Patients will be divided randomly into two groups of high-flux and low-flux filters after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: All of the patients had phosphate more than 6 mg/dl, although they were receiving medical treatment. Patients in high-flux group will be dialysed for two months with high-flux filters and patients in low-flux groups dialysed for two months with low-flux filters. Phosphate, lipid profile and hemoglobin will be measure before and after the two months period. Inclusion criteria: Age between 10-85 years old; patient is hemodialyzed for at least 6 months. Exclusion criteria: Patients using phosphate binder drugs irregularly; patients who are attending for hemodialysis irregularly. (4) Interventions: Sixty patients assigned into two groups of 30; hwmodialysis with low-flux filter and hemodialysis with high-flux filter and finally phosphate, lipid profile and hemoglobin will be measure before and after the two months period. (5) Main outcome measures: Serum phosphate level, lipid profile and hemoglobin which will be measured before starting the study and two months after hemodialysis.
General information
Acronym
ESRD
IRCT registration information
IRCT registration number:IRCT201306136123N2
Registration date:2013-06-28, 1392/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Seyed Sadraddin Rasi Hashemi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
rasihashemis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Scienses
Expected recruitment start date
2012-12-25, 1391/10/05
Expected recruitment end date
2013-05-26, 1392/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of comparing hemodialysis with high-flux and low-flux filters in controlling hyperphosphatemia in patients with end stage renal disease
Public title
Comparison of two kinds of hemodialysis filters in controlling serum phosphate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 10-85 years old; patient is hemodialyzed for at least 6 months.
Exclusion criteria: Patients using phosphate binder drugs irregularly; patients who are attending for hemodialysis irregularly.
Age
From 10 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee، Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2011-03-26, 1390/01/06
Ethics committee reference number
90106
Health conditions studied
1
Description of health condition studied
End stage renal disease treated with dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
2
Description of health condition studied
Instrumentation used in hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis
Primary outcomes
1
Description
Serum phosphate level
Timepoint
Before starting the study and two months after hemodialysis
Method of measurement
Laboratory kit
2
Description
hemoglobin
Timepoint
Before starting the study and two months after hemodialysis
Method of measurement
Laboratory kit
3
Description
Lipid profile
Timepoint
Before starting the study and two months after hemodialysis
Method of measurement
Laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
In low-flux group, patients will be hemodialysed with low-flux filter for two months
Category
Treatment - Devices
2
Description
In high-flux group, patients will be hemodialysed with high-flux filter for two months
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hesam Rasoul Amini
Street address
Department of Internal diseases, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Hesam Rasoul Amini
Position
General Practitioner
Other areas of specialty/work
Street address
Department of Internal diseases, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+41 13341317
Fax
Email
hesam_a6@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Dr. Seyyed Sadreddin Rasi Hashemi
Position
Assistant Professor/ Specialist in nephrology
Other areas of specialty/work
Street address
Department of Internal medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
rasihashemis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Hesam Rasoul Amini
Position
General Practitioner
Other areas of specialty/work
Street address
Department of Internal diseases, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
hesam_a6@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)