Aim: to study the effects of increased dialysis adequacy measured by Kt/V on uremic pruritus
Inclusion Criteria: being on chronic hemodialysis for more than 3 months; presence of pruritus
Exclusion criteria: any kind of allergic, dermatologic or hepatic disease which can be associated with pruritus.
Statistical population: all the patients under hemodialysis in Imam Hospital
Sample sizae: at least 6 patients
Intervention: Increasing dialysis adequacy by increasing dialysis time or increasing the blood flow, or using dialysis membranes of hieghr efficiency or higher flux
Intervention period: 12 weeks
Primary outcome: change in the severity of pruritus measured by Visual Analogue Scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111027973N1
Registration date:2012-02-16, 1390/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Seyed Mansour Gatmiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2679
Email address
gatmiri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-07-02, 1391/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Increased Dialysis Adequacy Measured by Kt/V index on Uremic Pruritus in Hemodialysis Patients of Imam Khomeini Hospital in 2012
Public title
Effect of More Adequate Dialysis on Itching in Dialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:being on hemodialysis for more than 3 months; presence of pruritus
Exclusion citeria: Any kind of active allergic, dermatologic or hepatic disease to which the pruritus can be attributable.
Age
From 17 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Nephrolrgy Research Center of Tehran University of Medical Sciences
Street address
Nephrology Research Center, Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733141
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90-03-14-13208-44796
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
Severity of Pruritus
Timepoint
at the end of the 12th week
Method of measurement
Using visual analogue scale and questionnaire
Secondary outcomes
1
Description
patients' quality of sleep
Timepoint
at the end of the 12th week
Method of measurement
Using questionnaire
Intervention groups
1
Description
Increasing Kt/V via increasing blood flow in access or using a higher efficiency membrane or using a higher flux membrane or increasing the time of dialysis.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyed Mansoor Gatmiri
Street address
Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology Research Center of Teahran University of Medical Sciences
Full name of responsible person
Seyed Mansoor Gatmiri
Street address
Nephrology Research Center, Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
90-03-14-13208
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center of Teahran 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
Nephrology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Seyed Mansoor Gatmiri
Position
Nephrologist
Other areas of specialty/work
Street address
Nephrology Research Center, Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehan
Postal code
1419733141
Phone
+98 21 6119 2679
Fax
+98 21 6658 1568
Email
gatmiri@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nephrology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Seyed Mansoor Gatmiri
Position
Nephrologist
Other areas of specialty/work
Street address
Nephrology Research Center, Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2679
Fax
+98 21 6658 1568
Email
gatmiri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nephrology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Azin Mohebi Nejad
Position
General Practitioner
Other areas of specialty/work
Street address
Nephrology Research Center, Dialysis Ward, Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2679
Fax
+98 21 6658 1568
Email
a-mohebinejad@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)