Evaluation the effect of hemodialysis fluid cooling on quality of sleep, uremic pruritus and hemodialysis efficiency in patients who are treated with hemodialysis in Semnan.
The aim of this study is to survey effect of cooling hemodialysis fluid on sleep quality, uremic pruritus and hemodialysis efficiency. All of the patients referred to hemodialysis center in Semnan city who treated with hemodialysis more than 6 months, dialysis three times per week for four hours, and who have not any acute disorders were selected as sample. At first, these patients are treated with 37 centigrade hemodialysis fluid for four weeks. Then the same patients are treated four weeks with 35 centigrade hemodialysis fluid and the same setting of apparatus and type of filter. Sleep quality, uremic pruritus, and hemodialysis efficiency were be compared in two stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203316481N3
Registration date:2012-04-09, 1391/01/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of hemodialysis fluid cooling on quality of sleep, uremic pruritus and hemodialysis efficiency in patients who are treated with hemodialysis in Semnan.
Public title
Evaluation the effect of hemodialysis fluid cooling on sleep, pruritus and hemodialysis efficiency in patients with hemodialysis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
1.Patients who have arteriovenous fistula for hemodialysis
2.Patients with constant blood flow rate during hemodialysis in control and test stages
3.Patients who have similar filter type and equal filter ultra-filtration coefficient during control and test stage.
4.Patients with hemodialysis three times a week and each time four hours.
5.Patients with hemodialysis at least 6 months before.
Exclusion criteria:
1-Patients with acute disease.
2-Patients with skin disorders that cause the itching.
3-Patients with skin allergy symptoms.
4-Patients who are treated with anti-itching drugs
5-Patients who stop hemodialysis related to any causes
6-Patients who are refered to renal transplantation
7-Patients with acure relal failure
8-Change in frequency of hemodialysis
9-Patients receive NSAID drugs such as Acetaminophen
10-Patients with psychotic disorders
11-Patients with psychosomatic disorders and receive with drugs that affect in sleep.
12-Hemodialysis with acetate fluid.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
At first the patients are in control group and then in test group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
3513138111
Approval date
2012-03-10, 1390/12/20
Ethics committee reference number
A-10-18-4.713
Health conditions studied
1
Description of health condition studied
Patients who are treated with hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Renal Failure
Primary outcomes
1
Description
Sleep Quality
Timepoint
Weekly
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Uremic pruritus
Timepoint
Weekly
Method of measurement
Pruritus score
3
Description
Hemodialysis efficiency
Timepoint
Weekly
Method of measurement
Urea Reduction Ratio
Secondary outcomes
empty
Intervention groups
1
Description
Stage 1: temprature of hemodialysis fluid (dialysate) is regulated on 37 degree of Cecilius. Type of filter, coefficient of ultra-filtration, blood flow rate and type of apparatus are constant during the study.
Category
Treatment - Other
2
Description
Stage 2: temperature of hemodialysis fluid is regulated on 35 degree of Celsius and type of filter, coefficient of ultra-filtration, blood flow rate are not changed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Semnan
Full name of responsible person
Mohsen Soleimani
Street address
Nursing faculty and Allied Health, Semnan University of Medical Sciences, Semnan.
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Vice Chancellor for Research, Semnen University of Medical Sciences, Basij Avenue, Semnan.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Ph.D
Other areas of specialty/work
Street address
Nursing faculty and Allied Health, Semnan University of Medical Sciences, Semnan.
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4191
Fax
Email
soli257@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Ph.D
Other areas of specialty/work
Street address
Nursing Faculty and Allied Health, Semnan University of Medical Sciences, Semnan.
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4191
Fax
+98 23 1335 4177
Email
Soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen soleimani
Position
Ph.D
Other areas of specialty/work
Street address
Nursing Faculty and allied Health, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4191
Fax
+98 23 1335 4177
Email
Soli257@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)