Determining the effect of low sodium level of dialysis fluid on hemodynamics of chronic hemodialysis patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 80 patients. Data analysis will be done with spss software.
Settings and conduct
It was done in a double-blind manner. The patients are divided into two groups of 40 people, they undergo hemodialysis with 135 and 140 sodium dialysis liquid, and after three months, the effect of dialysis liquid sodium on hemodynamics and the complications caused by it are investigated in the two groups. Golestan and Imam (RA) Ahvaz Hospital Dialysis Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: adults undergoing chronic hemodialysis
Inclusion criteria: active infection, ascites, uncontrolled blood pressure, age less than 18 and more than 60 years, complications during dialysis if not due to sodium reduction in dialysis fluid.
Intervention groups
Reducing sodium in dialysis fluid (135) in order to reduce blood pressure and weight of chronic hemodialysis patients in the intervention group and no change in sodium in dialysis fluid (140) in the control group
Main outcome variables
Hypotension, muscle cramps
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058662N1
Registration date:2023-08-09, 1402/05/18
Registration timing:prospective
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Azin Amoozadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 990 9989
Email address
azinamoozadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low sodium level in dialysis fluid on patients hemodynamic undegoing chronic hemodialysis
Public title
The effect of low sodium level in dialysis fluid on patients hemodynamic undegoing chronic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults on chronic hemodialysis
Exclusion criteria:
Age less than 18
Age more than 60
Uncontrolled underlying disease
Presence of active infection
Ascites
Sodium less than 130
Hypotension
Muscle cramps
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patient and the therapist are uninformed, and among the patients undergoing chronic hemodialysis in the mentioned dialysis centers, they are randomly divided into two groups with sodium 135 and sodium 140 dialysis fluid based on the bed number (even or odd) And the nurse in charge of the dialysis department only knows about dialysis fluid sodium, and all patient information is recorded by another nurse who does not know about dialysis fluid sodium.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the researcher, and the treatment staff are kept blind, and dialysis liquid sodium is adjusted by a nurse not related to the research
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan Hospital, Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2023-05-27, 1402/03/06
Ethics committee reference number
IR.AJUMS.REC.1402.122
Health conditions studied
1
Description of health condition studied
Chronic hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Decrease of blood pressure
Timepoint
The beginning of the study and months 1, 2 and 3
Method of measurement
Mercury sphygmomanometer
2
Description
Reduction of patient antihypertensive drugs
Timepoint
The beginning of the study and months 1, 2 and 3
Method of measurement
Mercury sphygmomanometer and history
3
Description
Decrease of weight
Timepoint
The beginning of the study and months 1, 2 and 3
Method of measurement
Scales
4
Description
Muscle cramps
Timepoint
The beginning of the study and months 1, 2 and 3
Method of measurement
History and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dialysis liquid sodium 135, hemodialysis three to four times a week for three months
Category
Treatment - Other
2
Description
Control group: dialysis liquid sodium 140, hemodialysis three to four times a week for three months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Ahvaz Hospital Hemodialysis Center
Full name of responsible person
Asieh Aref
Street address
Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3573 3118
Fax
+98 61 3337 4058
Email
info@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Hemodialysis Center of Imam khomeini Ahvaz Hospital
Full name of responsible person
Fatemeh Hayati
Street address
24 meter street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 3985
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asieh Aref
Street address
Golestan Boulevard,West saheli Boulevard
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Azin Amoozadeh
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Farvardin St , West saheli Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3374 3001
Email
azinamoozadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asieh Aref
Position
Academic board
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Farvardin Street ,West saheli Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3374 3001
Email
aref-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asieh Aref
Position
Academic board
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Farvardin Street, West saheli Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3374 3001
Email
aref-a@ajums.ac.ir
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
Not applicable
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