Objectives: To assess the effect high flux versus low flux on the quality of life in hemodialysis patients.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible hemodialysis patients who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 70 years; (b) a history of hemodialysis for at least 3 months.
Exclusion criteria: (a) having acute cardiovascular or respiratory disease; (b) needing to transfusion; (c) having moderate or severe depression; (d) low level of conscious or agitation.
Intervention group: Using high flux thrice a week for 12 weeks.
Control group: Using low flux thrice a week for 6 weeks and then using low flux twice a week and high flux once a week for another 6 weeks.
Primary outcome: Assessing the quality of life using quality of life questionnaire for hemodialysis patients (KDQOL-SF) before and 6 and 12 weeks after intervention.
Secondary outcome: Assessing the life satisfaction using satisfaction with life scale (SWLS) before and 6 and 12 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506099014N68
Registration date:2015-06-17, 1394/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-17, 1394/03/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-07-29, 1393/05/07
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high flux versus low flux on the quality of life in hemodialysis patients: a single blind randomized clinical trial
Public title
Effect of high flux versus low flux on the quality of life in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 70 years; (b) a history of hemodialysis for at least 3 months.
Exclusion criteria: (a) having acute cardiovascular or respiratory disease; (b) needing to transfusion; (c) having moderate or severe depression; (d) low level of conscious or agitation.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of flux used. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
D/P/16/35/9/6168
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Assessing the quality of life
Timepoint
before and 6 and 12 weeks after intervention
Method of measurement
using quality of life questionnaire for hemodialysis patients (KDQOL-SF)
Secondary outcomes
1
Description
Assessing the life satisfaction
Timepoint
before and 6 and 12 weeks after intervention
Method of measurement
using satisfaction with life scale (SWLS)
Intervention groups
1
Description
Using high flux thrice a week for 12 weeks.
Category
Treatment - Devices
2
Description
Using low flux thrice a week for 6 weeks and then using low flux twice a week and high flux once a week for another 6 weeks
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mehri Safari
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Mehri Safari
Position
Nursing Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0704
Fax
Email
mehrisafari760@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital,
Full name of responsible person
Dr Khodayar Oshvadi
Position
Nursing PhD
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+81 38380704
Fax
Email
oshvandi2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)