Protocol summary
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Study aim
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The effect of ascending-descending profile of ultrafiltration along with sodium profile on blood pressure of hemodialysis patients
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Design
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The clinical trial is cross-over, with parallel groups, double-blind and with a sample size of 30
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Settings and conduct
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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 Torbat Heydarieh city.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: with chronic renal failure. Exclusion criteria: Unwillingness to participate in the study
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Intervention groups
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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.
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Main outcome variables
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Blood pressure
General information
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Reason for update
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The sample size was changed due to reaching the required sample size.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180429039463N5
Registration date:
2023-01-07, 1401/10/17
Registration timing:
registered_while_recruiting
Last update:
2024-01-07, 1402/10/17
Update count:
1
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Registration date
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2023-01-07, 1401/10/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-29, 1401/10/08
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Expected recruitment end date
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2023-03-01, 1401/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Effect of dialysis machine profile on blood pressure
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-12-26, 1401/10/05
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Ethics committee reference number
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IR.THUMS.REC.1401.031
Health conditions studied
1
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Description of health condition studied
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Chronic renal failure
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease (CKD)
Primary outcomes
1
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Description
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Blood pressure
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Timepoint
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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.
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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N/A
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Torbate-Heidaria University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main consequence after being unidentified will be shared
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When the data will become available and for how long
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Start the access period 6 months after Publish results
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To whom data/document is available
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Everyone
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Under which criteria data/document could be used
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The results obtained in this study can be used without restriction by researchers.
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From where data/document is obtainable
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Referring to Torbat Heidarieh Nursing and Midwifery Faculty
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What processes are involved for a request to access data/document
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After sending the email to the person responsible for the response process begins.
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Comments
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