The effect of ascending-descending profile of ultrafiltration along with sodium profile on systolic and diastolic blood pressure during the dialysis process in patients undergoing hemodialysis treatment.
The effect of ascending-descending profile of ultrafiltration along with sodium profile on blood pressure of hemodialysis patients
Design
The clinical trial is cross-over, with parallel groups, double-blind and with a sample size of 30
Settings and conduct
For each of the patients, six sessions with the routine method (in which the sodium concentration of the dialysis solution remained constant at 143 mmol/liter from the beginning to the end of the dialysis and the amount of ultrafiltration did not change), and six sessions with a combination of sodium profile and profile 1 Ultrafiltration of the B-Brown Dialog Positive 1 device (ascending-descending profile of ultrafiltration) of hemodialysis will be performed in the dialysis department of the 9th Day Hospital of Torbet Heydarieh city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: with chronic renal failure. Conditions of non-entry: Unwillingness to participate in the study
Intervention groups
This study will be conducted cross-sectionally and during two periods. Each of the patients underwent six sessions with the routine method (in which the sodium concentration of the dialysis solution remained constant at 143 mmol/liter from the beginning to the end of dialysis and the amount of ultrafiltration did not change), and six sessions with a combination of sodium profile and ultrafiltration profile 1. B-Brown Dialog Positive 1 device (ascending-descending ultrafiltration profile) will perform hemodialysis. Also, 4 wash-out sessions are planned for patients.
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039463N5
Registration date:2023-01-07, 1401/10/17
Registration timing:registered_while_recruiting
Last update:2023-01-07, 1401/10/17
Update count:1
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
mohammad namazinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 5280
Email address
namazinm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-29, 1401/10/08
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ascending-descending profile of ultrafiltration along with sodium profile on systolic and diastolic blood pressure during the dialysis process in patients undergoing hemodialysis treatment.
Public title
Effect of dialysis machine profile on blood pressure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-75
suffering from end-stage renal disease (GFR less than 10% in non-diabetics and non-elderly and GFR less than 15% in diabetics and the elderly)
Being on hemodialysis for more than six months
Dialysis three times a week with sodium bicarbonate buffer solution
Not having specific cardiovascular problems such as heart attack, atrial fibrillation or using a pacemaker
Not having severe anemia
Exclusion criteria:
Unwillingness to participate in the study
Try to get a vein or needle more than twice in each vascular pathway
Fistula failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be informed that they will participate in a study, but they will not know that they are in the control group or in the intervention group.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences
Street address
Torbat Heydariyeh University of Medical Sciences, Razi St., Torbat Heydariyeh, Iran
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.THUMS.REC.1401.031
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Blood pressure
Timepoint
In this study, blood pressure is measured before dialysis, the first hour, the second hour, the third hour, the fourth hour, and after each dialysis session.
Method of measurement
Each of the samples rested in the supine position after baring the hand with the hand of the sphygmomanometer while the cuff of the device was closed at least 2.5 to 3 cm above the elbow and was measured and recorded.
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: In the ascending-descending ultrafiltration profile mode, the duration of dialysis is routinely considered to be 4 hours. Ultrafiltration in this hemodialysis program is divided into three phases (ascending, intermediate and venular). In the ascending phase, 25.5% of the patient's total weight is taken with a low UF rate. In the middle phase, there is an aggressive phase that takes 51.2% of the patient's weight, which is the maximum UF rate in this phase. In the descending phase, 23.6% of the total weight of the patient is taken, and the UF rate of this phase is also low.
Category
N/A
2
Description
Control group: In routine mode without ultrafiltration profile, the patient's weight is divided every hour, weighing is taken to balance. For example, in a patient who has 4 liters of excess weight during 4 hours of hemodialysis, the ultrafiltration rate is 1000 ml per hour.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
تربت حیدریه
Province
Razavi Khorasan
Postal code
95195481$6
Phone
+98 51 5222 6014
Email
mnamazi99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rezaei Manesh
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 8023
Email
mnamazi99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Torbate-Heidaria University of Medical Sciences
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main consequence after being unidentified will be shared
When the data will become available and for how long
Start the access period 6 months after Publish results
To whom data/document is available
Everyone
Under which criteria data/document could be used
The results obtained in this study can be used without restriction by researchers.
From where data/document is obtainable
Referring to Torbat Heidarieh Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.