The aim of this study is Comparison the effect of blood flow rate and dialysate change on comfort and dialysis adequacy of the patient under hemodialysis.35 patients under hemodialysis, between 18 to 65 years old, who are receiving hemodialysis three times a week for 4 hours in each session and have at least the history of one year of hemodialysis are selected. before each dialysis a check list included patients hemodialysis features is filled out and then the patient is connected to the machine.before dialysis a blood sample of arterial set is provided. in the first session of hemodialysis the blood flow rate is set on 250 and the dialisate flow rate is set on 500 ml/min, in the second session the blood flow rate is set on 250 and the dialisate flow rate is set on 800 ml/min,in the third session the blood flow rate is set on 300 and the dialisate flow rate is set on 500 ml/min,in the fourth session the blood flow rate is set on 300 and the dialisate flow rate on 800 ml/min.in the end of each hemodialysis session and before separation the patient from the machine ,a blood sample of arterial set is provided again.research units are checked for urea.ultrafiltration rate is gained of the difference between weight of before and after dialysise . after receiving the result of blood urea nitrogen , Daugirdas II formula which is one of the acceptable ones in the world is used to determine the dialysis adequacy.in each sessions ,the patients are evaluated for comfort by the visual comfort scale and researcher structured quesstionare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030726947N1
Registration date:2016-06-15, 1395/03/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Mina Begian
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
m.begian@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of blood flow rate and dialysate change on comfort and dialysis adequacy of the patient under hemodialysis
Public title
The effect of blood flow rate and dialysate change of the patient under hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18 to 65 years old; Having arteriovenous fistula; Receiving hemodialysis three times a week; 4 hours dialysis in each session; lack of intolerance dialysis in sessions;The desire to participate in the study; Patients without a history of cardiovascular diseases; At least the history of one year of dialysis
Exclusion criteria :lack of cooperation by the patient; Cardiac and pulmonary disease in patient; Kidney transplant; The patient died
Age
From 18 years old to 65 years old
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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
6517838698
Approval date
2016-03-03, 1394/12/13
Ethics committee reference number
IR.UMSHA.REC.1394.525
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Dialysis Adequacy
Timepoint
Before and After Hemodialysis Session
Method of measurement
The result of blood urea nitrogen before and after hemodialysis , Daugirdas II formula
2
Description
Comfort
Timepoint
End of Hemodialysis
Method of measurement
Visual comfort scale and Researcher structured quesstionare
Secondary outcomes
empty
Intervention groups
1
Description
In all the patients, in the first session of hemodialysis the blood flow rate is set on 250 and the dialisate flow rate is set on 500 ml/min, in the second session the blood flow rate is set on 250 and the dialisate flow rate is set on 800 ml/min,in the third session the blood flow rate is set on 300 and the dialisate flow rate is set on 500 ml/min,in the fourth session the blood flow rate is set on 300 and the dialisate flow rate on 800 ml/min.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Besat Hospital
Full name of responsible person
Mina Begian
Street address
Besat Hospital, shahid Beheshti Street, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Vice-Chancellor Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Research and Technology Vice-Chancellor, Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellor Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seid Reza Borzou
Position
PhD of Nursing/Assisstant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
borzou@umsha.ac.ir
Web page address
http://www.umsha.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seid Reza Borzou
Position
PhD of Nursing/ Assisstant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
borzou@umsha.ac.ir
Web page address
http://www.umsha.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mina Begian
Position
Master of Science of Nursing/ Nurse
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
m.begian@edu.umsha.ac.ir
Web page address
http://www.umsha.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)