To determine the dialysate sodium concentration that results in normotensive response during hemodialysis
Design
Pragmatic, community based, parallel group, single blind, randomized controlled trial. Sample size would be 105.
Settings and conduct
Study would be conducted in Hemodialysis Centre of Pak Emirates Military Hospital, Rawalpindi , Punjab, Pakistan.
Patients have been blinded and they would not know that to which group of dialysate sodium concentration they belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 18 years or more
2. Either Genders
3. CKD patients undergoing routine hemodialysis for 3 months or more
4. Hemodynamically stable patients
Exclusion criteria:
1. Age less than 18 years
2. Patients undergoing routine hemodialysis for less than 3 months
3. Patients undergoing hemodialysis for causes other than CKD
4. Hemodynamically Unstable patients
5. Ongoing Sepsis, Active Cancer, MI''
6. Patient's unwillingness
Intervention groups
Group 1: Dialysate Sodium Concentration of 135 mEQ
Group 2: Dialysate Sodium Concentration of 140 mEQ
Group 3: Dialysate Sodium Concentration of 145 mEQ
Main outcome variables
Hypertension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240321061342N1
Registration date:2025-02-20, 1403/12/02
Registration timing:retrospective
Last update:2025-02-20, 1403/12/02
Update count:0
Registration date
2025-02-20, 1403/12/02
Registrant information
Name
Muhammad Abdul Haseeb Siddiqui
Name of organization / entity
National Universiry of Medical Sciences
Country
Pakistan
Phone
+92 51 5157412
Email address
haseeb9876@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-01, 1403/07/10
Expected recruitment end date
2024-10-15, 1403/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different dialysate sodium concentrations on blood pressure response during hemodialysis
Public title
Effect of different dialysate sodium concentrations on blood pressure response during hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 or greater
Either Genders
CKD patient on regular hemodialysis for 3 months or more
Hemodynamically stable patient
Exclusion criteria:
Age less than 18 years
Patient undergoing dialysis for reasons other than CKD
CKD patient undergoing rountine hemodialysis for less than 3 months
Hemodynamically Unstable patient
Ongoing sepsis, active cancer
Patient unwillingness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done. Each participant is randomly assigned to a treatment group using a random number generator.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study would not know that to which group of dialysate sodium concentration during hemodialysis they have been allotted to.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pak Emirates Military Hospital Ethical Committee
Street address
Pak Emirates Military Hospital, Abid Majeed Road, Saddar , Rawalpindi Cantt.
City
Rawalpindi
Postal code
45000
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
A/28/ERC/27/24
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Blood pressure Response during hemodialysis with different dialysate sodium concentrations
Timepoint
Blood pressure before, 2 hours midway dialysis and after completion of hemodialysis.
Method of measurement
Measure blood pressure with sphygmomonometer
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group 1: Dialysate Sodium Concentration of 135 mEQ during hemodialysis
Category
Treatment - Other
2
Description
Intervention group 2: Dialysate Sodium Concentration of 140 mEQ during hemodialysis
Category
Treatment - Other
3
Description
Intervention group 3: Dialysate Sodium Concentration of 145 mEQ during hemodialysis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Centre of Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Dr Muhammad Abdul Haseeb Siddiqui
Street address
Pak Emirates Military Hospital, Abid Majeed Road, Saddar
City
Rawalpindi
Postal code
45000
Phone
+92 313 5411980
Email
haseeb9876@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Muhammad Abdul Haseeb Siddiqui
Street address
NUMS, The Mall Road, Saddar , Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 313 5411980
Email
haseeb9876@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National 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
Pak Emirates Military Hospital
Full name of responsible person
Dr Muhammad Abdul Haseeb Siddiqui
Position
Registrar Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Pak Emirates Military Hospital, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
45000
Phone
+92 313 5411980
Email
haseeb9876@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Dr Abdul Rehman Arshad
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Abid Majeed Road, Saddar
City
Rawalpindi
Province
Punjab
Postal code
45000
Phone
+92 313 5411980
Email
haseeb9876@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Dr Muhammad Abdul Haseeb Siddiqui
Position
Registrar Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abid Majeed Road, Saddar , Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
45000
Phone
+92 313 5411980
Email
haseeb9876@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
No - There is not 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
No - There is not 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
It will be available on contacting via provided email ID.
When the data will become available and for how long
After publication of research article.
To whom data/document is available
It will be available on contacting via provided email ID.
Under which criteria data/document could be used
Will be provided to medical professionals upon contacting and stating their need for data.
From where data/document is obtainable
It will be available on contacting via provided email ID.
What processes are involved for a request to access data/document
It will be available on contacting via provided email ID.
Comments
It will be available on contacting via provided email ID.