Examination of cardiac function in chronic hemodialysis patients with low sodium levels in the dialysis fluid
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 80 patients.
Settings and conduct
It was done in a double-blind manner. The patients are divided into two groups of 40 people, they are subjected to hemodialysis with dialysis liquid sodium 135 and 140, and after three months, the effect of dialysis liquid sodium on hemodynamics and its complications are investigated in two groups in Golestan and Imam Ahvaz Hospital Dialysis Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adults under chronic hemodialysis. Exclusion criteria: active infection, ascites, uncontrolled blood pressure, age less than 18 and more than 60 years, complications during dialysis if not due to sodium depletion of the dialysis fluid.
Intervention groups
Reduction of dialysis fluid sodium (135) in order to reduce blood pressure and weight of chronic hemodialysis patients in the intervention group and no change of dialysis fluid sodium (140) in the control group
Main outcome variables
Blood pressure; Muscle cramps
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230824059250N1
Registration date:2023-08-30, 1402/06/08
Registration timing:prospective
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Masud Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 114 8109
Email address
rahmani.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the cardiac function in chronic hemodialysis patients with low sodium levels in the dialysis fluid
Public title
The effect of low sodium level of dialysis fluid on cardiac function of chronic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults undergoing chronic hemodialysis
Exclusion criteria:
Age less than 18, age more than 60
Uncontrolled underlying disease
Presence of active infection
Sodium acetate less than 130
Low blood pressure
Muscle cramps
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligibility criteria will be divided into two groups using a randomized block design. An online website (https://www.sealedenvelope.com) generates a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 40 people are selected for the first intervention group and 40 for the second intervention group. While the patients and the therapist do not know the amount of sodium received.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the researcher, and the treatment staff are kept blind, and sodium dialysis liquid is adjusted by a nurse not related to the research
Placebo
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
Farvardin Street, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2023-05-27, 1402/03/06
Ethics committee reference number
IR.AJUMS.REC.1402.123
Health conditions studied
1
Description of health condition studied
Chronic hemodialysis
ICD-10 code
I95.3
ICD-10 code description
Hypotension of hemodialysis
Primary outcomes
1
Description
Blood pressure
Timepoint
The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention
Method of measurement
Mercury sphygmomanometer
2
Description
Muscle cramps
Timepoint
The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention
Method of measurement
History and physical examination
3
Description
Efficacy of blood pressure lowering drugs used by the patient
Timepoint
The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention
Method of measurement
Sphygmomanometer and history
Secondary outcomes
1
Description
Weight
Timepoint
The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention
Method of measurement
scale
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
Intervention group: Sodium dialysis fluid, 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
Ekhlas Torfi
Street address
Farvardin St
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3314 0000
Fax
+98 61 3314 0000
Email
torfi-e@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Hemodialysis Center, Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Masud Rahmani
Street address
24 meter street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 912 114 8109
Email
rahmani.ma@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Farvardin St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
zakerkish-m@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
Masud Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farvardin Street, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3314 0000
Email
rahmani.ma@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masud Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farvardin Street, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3314 0000
Email
rahmani.ma@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masud Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farvardin Street, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3314 0000
Email
rahmani.ma@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