Determine the Effect of Stepwise profile of Fluid flow and increase Blood flow on the Adequacy of Hemodialysis
Design
cross-over clinical trial which was conducted in two sequences ,Randomised, has control and intervention group.
Settings and conduct
This study included hemodialysis patients in Bu ali hemodialysis unit. So the total examination of patients, those that include the criteria for entry, isolated, 34 patients from randomly selected patients from the criteria of entry. After explaining the study method to patients, they are informed consent. These patients are examined in 2 phases. In the first phase, half of the patients receive 4 sessions in routine and the other half in 4 sessions by dialysis and blood flow profiling. In the second phase, two dialysis methods are transmitted between the two groups. The adequacy of hemodialysis is calculated and compared in two methods.
Participants/Inclusion and exclusion criteria
inclusion criteria: ESRD; three 4-hour sessions of dialysis per week; passing at least 3 months of treatment with hemodialysis; having a fistula; ability to participate in project; Age was above of 18 years.
Exit criteria:active infection; referenced from other centers; heparin-free dialysis; Hospitalization for transplantation; Order Dialysis time less than 3:45
Intervention groups
The control group received 4 sessions of routine Hemodialysis for 3:45 hours.
Patients in the intervention group, 4 sessions, are hemodialized by stepwise fluid flow profiling and increased blood flow.
Main outcome variables
the amount of Blood urea clearance and Hemodialysis Adequacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180407039218N1
Registration date:2018-06-12, 1397/03/22
Registration timing:retrospective
Last update:2018-06-12, 1397/03/22
Update count:0
Registration date
2018-06-12, 1397/03/22
Registrant information
Name
Afsaneh Dashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
a.dashti@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-05-30, 1397/03/09
Actual recruitment start date
2018-05-31, 1397/03/10
Actual recruitment end date
2018-06-05, 1397/03/15
Trial completion date
empty
Scientific title
Effect of Stepwise profile of Fluid flow rate and increase Blood flow rate in Adequacy of Hemodialysis in Hemodialysis patients
Public title
Effect of Stepwise profile of Fluid flow rate and increase Blood flow rate in Adequacy of Hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a chronic renal failure and hemodialysis treatment
Age over 18 years.
Are willing to participate in the research
Brachial arterial fistula
More than three months from the onset of hemodialysis
There are 3 dialysis sessions per week
Not having hepatitis, AIDS and septicemia
Not under chemotherapy
Do not have a history of bleeding
Acute heart failure
Exclusion criteria:
Dialysis order is less than 3:45
Patients with active infection
Patients referenced from other centers
Patients with heparin-free dialysis
Hospitalization for transplantation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences., Navab Ave., Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-02-07, 1396/11/18
Ethics committee reference number
IR.QUMS.REC.1396.418
Health conditions studied
1
Description of health condition studied
Hemodialysis Adequacy
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis
Primary outcomes
1
Description
Hemodialysis adequacy value
Timepoint
Calculate the adequacy of hemodialysis after each hemodialysis session
Method of measurement
Hemodialysis machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, each patient hemodialized 4 sessions according to the stepwise fluid flow profile and increased blood flow.To implement this method, the patient is first connected to the B-braun (Dialog+) hemodialysis machine.After entering the patient's basic information such as height, weight, age, and gender, go to the dialysis fluid flow settings section, then select the step chart option.The maximum value is set to 800 cc / min and the minimum is 500 cc / min.Then, based on the patient's weight, if it was less than 65 kg, 15% or more than 65 kg, we would add 20% to the amount of base blood pump.Once again, go to the device configuration section and enable the Dialysis Compilation Calculation (KT / V) option by completing the patient's basic information.The patient's dialysis time should not be less than 3:45. At the end of the dialysis, we will write the numerical value of dialysis adequacy from the dialysis machine. The dialysis adequacy value is calculated after each dialysis session.
Category
Other
2
Description
Control group: In this group, patients hemodialized 4 sessions with routine dialysis method. There are no changes or interventions in this group. At the end of each session, we will record the numerical value of dialysis adequacy (kt / v) calculated by the machine online.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Afsaneh Dashti
Street address
Bu Ali Hospital., Bu Ali Ave
City
Qazvin
Province
Qazvin
Postal code
3375157317
Phone
+98 28 3333 2930
Fax
+98 28 3332 6033
Email
boali.hospital@qums.ac.ir
Web page address
http://hosbooali.qums.ac.ir/Portal/home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences., Navab Ave., Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3332 4970
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Afsaneh Dashti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences., Navab Ave., bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3471875517
Phone
+98 28 3333 6001
Fax
Email
Afsandashti910@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Afsaneh Dashti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences., Navab Ave., bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3471875517
Phone
+98 28 3333 6001
Fax
Email
Afsandashti910@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Afsaneh Dashti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences., Navab Ave., bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3471875517
Phone
+98 28 3333 6001
Fax
Email
Afsandashti910@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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