About the quality of life for hemodialysis patients in Iran have been many studies all indicate the quality of life in this group are low. But in terms of quality of life and ways of correcting anemia and low solution cost are sometimes offered. This study aimed to determine the impact on quality of life for hemodialysis liquid-based cooling and the health of anemia in hemodialysis patients are diagnosed with end stage renal disease.
After selecting the samples, the patients were randomly assigned to two equal groups (n = 30) will be divided. The first group, 4 weeks with standard dialysis (37 ° C) and 4-week dialysis cold (35 ° C) and the second group, 4-week dialysis cold (35 ° C) and 4 weeks with standard dialysis (37 ° C) will be. Hemodialysis. The term quality of life in three stages before the first 4 weeks, 4 weeks after completion and finishing second four weeks using a 36-item Short questionnaire quality of life (SF-36) will be. The hemoglobin level will be measured in the same steps. To determine hemoglobin samples from hemodialysis machine venous line is.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062722930N1
Registration date:2017-09-11, 1396/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Fatemeh Morady
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 2513
Email address
moradifha@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-06-30, 1394/04/09
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of cold dialysis fluid based on quality of life and health of anemia in hemodialysis patients.
Public title
Cold hemodialysis effect on quality of life and anemia.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study included(Type of vascular access is a fistula; Round pump, type and UF filtration and hemodialysis devices Standard hemodialysis and cooled in two stages before and after the intervention to be fixed; Patients on hemodialysis three times a week and each session will be 4 hours; At least 6 months prior to their undergoing hemodialysis).
Exclusion criteria were(Patients with acute physical and psychological problems (such as divorce, death of a loved one, financial problems, create new chronic disease) only in one of the courses are standard hemodialysis or cold; Patients undergoing hemodialysis them for any reason (kidney transplantation, vascular access problem) is interrupted; Patients who are on dialysis due to acute kidney failure; dialysis patients regime change them for any reason; Patients who are treated for mental health problems; patients who are experiencing acute bleeding; blood transfusion patients who receive).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan. Azadi Square
City
Zanjan
Postal code
Approval date
2015-07-01, 1394/04/10
Ethics committee reference number
856
Health conditions studied
1
Description of health condition studied
ESRD
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Quality of life
Timepoint
Baseline,The first 4 weeks after sampling, The second four weeks after sampling
Method of measurement
SF36
2
Description
Anemia
Timepoint
Baseline, the end of each week In the first 4 weeks and In thesecond 4 weeks After sampling
Method of measurement
cell count
Secondary outcomes
empty
Intervention groups
1
Description
Naturally hemodialysis fluids for dialysis patients is 37 ° C. The study used groups of 35 ° C. A cross-over study that temperature change (intervention) in the intervention group runs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Vali-asr Hospital
Full name of responsible person
Street address
Above Vali-Asr Square
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Morady
Street address
Zanjan, Town officials, School of Nursing and Midwifery
City
Zanjan,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
Master Sciences of Nursing/Faculty Member
Other areas of specialty/work
Street address
Znjan. Nursing University
City
Znjan
Postal code
Phone
00982433148353 - 00982433148367
Fax
Email
moradifha@gmail.com - moradifha@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
Master Sciences of Nursing
Other areas of specialty/work
Street address
Zanjan. nursing University
City
Zanjan
Postal code
Phone
00982433148353 - 00982433148367
Fax
Email
moradifha@gmail.com - moradifha@zuma.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Fatemeh Morady
Position
Master of Science in Nursing / Faculty
Other areas of specialty/work
Street address
Zanjan Azadi Square
City
Zanjan
Postal code
Phone
+98 24 3314 8353
Fax
Email
moradifha@gmail.com / moradifha@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)