Comparison of the effect of dialysates with 2meq/l and 3meq/l potassium as a result of adding KCl onserum potassium levels of patients before and after hemodialysis in hemodialysis patients
Comparison of the effect of dialysates with 2meq/l potassium and 2meq/l potassium as a result of adding KCl on serum potassium levels of patients before and after hemodialysis in hemodialysis patients
Design
A clinical trial with a control group, based on the community, with parallel groups, with the blinding of the data analyst, randomized phase3, on 160patients. For randomization, block randomization of four of the sites
sealedenvelope.com
Settings and conduct
First, the serum potassium of the patients will be measured.Then, the case group will undergo dialysis with 2meq/l potassium dialysate, to which17.5 cc ampoules of potassium chloride 15% added to each liter. The control group will undergo dialysis with 2meq/l potassium dialysate. After the end of dialysis, the serum potassium of the patients will be measured once again immediately and once 6hours after the end of dialysis.
In this blinding study the person in charge of analyzing and analyzing the data will not be aware of the intervention received by each person.
Hemodialysis Department of Khurshid Hospital, Isfahan
September 2022
Participants/Inclusion and exclusion criteria
Age more than20 years and less than75
Have a regular treatment plan and undergo hemodialysis 3times a week
Have a serum potassium level of less than and equal to4.5
Intervention groups
The group1 will undergo dialysis with2meq/l potassium dialysate, to which 17.5cc ampoules of potassium chloride 15% have been added to each liter of concentrated dialysate.
The group2 will undergo dialysis with 2meq/l potassium dialysate.
Main outcome variables
patients serum potassium before and after dialysis
dialysate potassium before and after dialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055361N1
Registration date:2023-02-19, 1401/11/30
Registration timing:retrospective
Last update:2023-02-19, 1401/11/30
Update count:0
Registration date
2023-02-19, 1401/11/30
Registrant information
Name
Mehran Haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 7276
Email address
haddadi.mehran@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dialysates with 2meq/l and 3meq/l potassium as a result of adding KCl onserum potassium levels of patients before and after hemodialysis in hemodialysis patients
Public title
Effect of Different dialysates on serum potassium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
hemodialysis for more than 3 months
stable physical and labaratory condition
regular treatment program (3 times dialysis per week)
stable vascular access
stable blood pressure
stable hemodynamic and cardiovascular condition
serum potassium less than or equal to 4.5
The patient should be hospitalized. (for the convenience of measuring potassium 6 hours after the end of dialysis)
Exclusion criteria:
need a blood transfusion for any reason
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use the block randomization method. For this purpose, the website https://www.sealedenvelope.com/ will be used.
40 blocks of 4 will be created by the site, which will assign 2 people to the Case group and 2 people to the Control group in each block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers"
Street address
Address: Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4 - University Research and Technology Vice-Chancellor
City
اصفهان
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.ARI.MUI.REC.1401.027
Health conditions studied
1
Description of health condition studied
hyperkalemia in hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
serum potassium level
Timepoint
Measurement of serum potassium in patients before dialysis, immediately after dialysis, 6 hours after dialysis
Method of measurement
Serum potassium measurement of patients in the laboratory by electrode method and using EasyLyte REF 2124 device
2
Description
dialysate potassium level
Timepoint
Measurement of potassium level of dialysate during dialysis from afferent and efferent coupling
Method of measurement
dialysate potassium measurement in the laboratory by electrode method and using EasyLyte REF 2124 device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dialysis with 2 meq/l potassium dialysate to which 17.5 cc ampoules of 15% potassium chloride have been added per liter of concentrated dialysis solution (equivalent to 3 meq/l solution)
Category
Treatment - Other
2
Description
Control group: Dialysis with 2 meq/l potassium dialysate
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
khorshid medical educational research complex
Full name of responsible person
Abdolamir Atapour
Street address
No. 105, Ostandari Street, Isfahan, Isfahan Province
City
Isfahan
Province
Hamadan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr gholamreza Asgari
Street address
building no.4, isfahan university of medical sciences, hezar jirib street, isfahan
City
isfahan
Province
Isfehan
Postal code
817467346
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Haddadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arjan apartment, kouchmeshki st, fatemieh blvd,
City
Hamadan
Province
Hamadan
Postal code
6515913463
Phone
+98 81 3821 7276
Fax
Email
Haddadi.mehran@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Haddadi
Position
general medicine student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
No. 1,Arjan apartment, koochmeshki Ave., Fatemieh Blvd., hamedan Town
City
hamedan
Province
Hamadan
Postal code
6515913463
Phone
+98 81 3821 7276
Email
haddadi.mehran@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Haddadi
Position
general medicine student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
No. 1,Arjan apartment, koochmeshki Ave., Fatemieh Blvd., hamedan Town
City
همدان
Province
Hamadan
Postal code
6515913463
Phone
+98 81 3821 7276
Email
haddadi.mehran@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
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