Protocol summary

Summary
The purpose of this study was to compare the effectiveness of the High Flux and Low Flux membranes on parathyroid hormone serum level in patients with secondary hyperparathyroidism undergoing chronic dialysis. Total of 40 patients referring to Tohid Hospital dialysis center in 2014 who passed inclusion criteria of the study were selected and using the table of random numbers randomly divided into two groups of 20. The control group with Low Flux membrane and the intervention group with High Flux membrane. In order to double blind the study, a colleague who had not sensitivity to study toke the blood samples, he also sent the samples to lab. Inclusion criteria included high level serum of parathyroid hormone (greater than 300pg / dl), performing dialysis by fixed means, dialysis three times a week for four hours, the patient should be at least 6 months on dialysis program, previous use of the Low Flux membrane, bearing on dialysis, age greater than 18 years, the ability to participate in the study and exclusion criteria included; patients with acute renal failure, patients with poor vascular access that may affect their quality of dialysis , age less than 18 years, the continued lack of patient cooperation, discontinuation of dialysis for any reason, being dialysis by High Flux membrane previously. In the beginning of the study for both groups blood samples were taken before dialysis. Laboratory evaluation included serum levels of phosphorus and parathyroid hormone were conducted. The use of Low Flux and High Flux membranes in the both groups continued for three months. Laboratory evaluation included serum levels of parathyroid hormone and phosphorus was repeated again In the end of the study for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121712789N10
Registration date: 2015-05-29, 1394/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-29, 1394/03/08
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of High Flux versus Low Flux membranes on the level of parathyroid hormone in patients with secondary hyperparathyroidism undergoing chronic dialysis
Public title
Comparing the High Flux versus Low Flux membranes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included high level serum of parathyroid hormone (greater than 300pg / dl), performing dialysis by fixed means, dialysis three times a week for four hours, the patient should be at least 6 months on dialysis program, previous use of the Low Flux membrane, bearing on dialysis, age greater than 18 years, the ability to participate in the study. Exclusion criteria included; patients with acute renal failure, patients with poor vascular access that may affect their quality of dialysis , age less than 18 years, the continued lack of patient cooperation, discontinuation of dialysis for any reason, being dialysis by High Flux membrane previously
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To make the study double blind, blood sample taking and sending the blood samples to laboratory was done by one of the colleagues working in dialysis ward. Also patients were not aware of their grouping and the kind of membrane used for their hemodialysis.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2014-09-03, 1393/06/12
Ethics committee reference number
14/21678

Health conditions studied

1

Description of health condition studied
Secondary hyperparathyroidism, not elsewhere classified
ICD-10 code
N25.8
ICD-10 code description
secondary hyperparathyroidism of renal origin

Primary outcomes

1

Description
level serum of parathyroid hormone
Timepoint
Beginning of the study - Three months after the study
Method of measurement
ELISA method

Secondary outcomes

1

Description
serum levels of phosphorus
Timepoint
Beginning of the study -Three months after the study
Method of measurement
The Prestige 24i Automated Analyzer

2

Description
Hemodialysis Adequecy
Timepoint
Beginning of the study -Three months after the study
Method of measurement
kt/v method

Intervention groups

1

Description
In the intervention group, patients who have been on dialysis with Low Flux membrane for three years would be on dialysis for three months with High Flux membrane.
Category
Treatment - Other

2

Description
In the control group, patients who previously had been dialyzed by Low Flux membrane for three years would be dialyzed again for three months using Low Flux membrane .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Rasol Azimi
Street address
Tohid Hospital, Basij Sq., Geriashan St., Sanandaj, Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
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, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Rasol Azimi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Tohid Hospital, Basij Sq., Geriashan St., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
rasoulazimi18@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Shahdak Dadashpour
Position
Assistant Proffesor
Other areas of specialty/work
Street address
Tohid Hospital, Basij Sq., Geriashan St., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
shahdakdadashpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Rasol Azimi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Tohid Hospital, Basij Sq., Geriashan St., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
rasoulazimi18@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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