Determination the effect of priming with heparin - normal saline on َadequacy of hemodialysis in hemodialysis Patients
Design
A randomized clinical trial with a control group, with two parallel groups
Settings and conduct
The present study is a randomized clinical trial on two groups of 72 patients undergoing hemodialysis in Hamedan. In the intervention group, hemodialysis device priming will be done for patients with normal saline plus heparin for one month. In the control group, priming will be performed using normal saline. The adequacy of hemodialysis patients will be examined using the adequacy calculation formula for hemodialysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Perform hemodialysis three times a week, End stage renal failure, Age 18 to 85 years old
exclusion criteria: Unwillingness to continue to participate in the study, Failure to perform hemodialysis regularly.
Intervention groups
In the intervention group, hemodialysis device priming will be done for patients with normal saline plus heparin(1000units) for one month.
Main outcome variables
Hemodialysis adequacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N25
Registration date:2019-07-28, 1398/05/06
Registration timing:prospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of priming with heparin and normal saline on adequacy of hemodialysis in hemodialysis patients
Public title
Effect of priming with heparin - normal saline on adequacy of hemodialysis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 85 years old
End stage renal failure
Perform hemodialysis three times a week
Exclusion criteria:
Unwillingness to continue to participate in the study
Failure to perform hemodialysis regularly
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into two groups intervention(A) and control (B).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.UMSHA.REC.1398.329
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Hemodialysis adquacy
Timepoint
Before and immediately after each hemodialysis
Method of measurement
Blood urea and creatinine measurements by blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the hemodialysis device priming will be done using normal saline plus 1000 units of heparin for one month.
Category
N/A
2
Description
Control group: In the control group, the priming of the hemodialysis device will be performed using normal saline.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Reza Borzou
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Tayebeh Nazaridoust
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
tnd621@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available