Determining the effect of cold fluid hemodialysis on the rate of nausea in patients under hemodialysis
Design
60 Patients under hemodialysis are randomly divided into two groups: cool dialysate and standard dialysate. The study is single blind clinical trial.
Settings and conduct
This study will be performed on 30 patients in the intervention group and 30 patients in the control group in the dialysis section Emam reza Hospital who have inclusion criteria and will randomly be divided into two groups. In this study , patients will be blinded. For 1 weeks, the intervention group is dialyzed at 36 ° C and the control group at 37 ° C is dialyzed. Amount of nausea in both groups will be evaluated with Visual Analogue Scale(VAS) at pre, intra & post dialysis
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Perform hemodialysis three times a week for 3-4 hours each time
History of hemodialysis for at least six months
Complete patient satisfaction to participate in this study
Be at least 18 years old and at most 65 years old
Do not take anti-nausea and vomiting medications
Exclusion criteria:
. Patients whose hemodialysis changes frequently and for whatever reason (changes in hemodialysis pattern).
. Patients with fever and chills
Death, travel or transfer of patients to other medical centers Patients'
Lack of willingness of patients to continue cooperation
Intervention groups
In the intervention group hemodialysis will be done using dialysis solution with a temperature of 36 ° C. In control group hemodialysis will be done with standard solution temperature of 37 ° C and will be assessed its effect on nausea.
Main outcome variables
Nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200530047597N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
yasem arghide
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3334 8119
Email address
arghideyasem@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cool temperature dialysate on nausea in hemodialysis patients
Public title
The effect of hemodialysis with cold fluid on nausea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Perform hemodialysis three times a week for 3-4 hours each time
History of hemodialysis for at least six months
Full patient satisfaction to participate in this study
Age older than 18 years and maximum 65 years
Do not take anti-nausea and vomiting medications
Exclusion criteria:
Patients whose hemodialysis changes for any reason and the duration (change in hemodialysis pattern).
Patients with fever and chills
Death, travel or transfer of patients to other medical centers
Lack of willingness of patients to continue cooperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First samples will be selected by convenience method according to inclusion and exclusion criteria. Then random assignment will be used with permuted blocking. R Software will be used to get the blocks. The blocks are made up of 4 English letters (A,B,C,D). A ,B will be considered for the intervention group, and other three letters (C, D) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DACB block means from left hand, first and third, respectively, will be located in the control group, and the second and fourth of participants will be located in the intervention group, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Dialysis patients are unaware of the classification of the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical sciences
Street address
Department2, SHahid beheshty street
City
kermanshah
Province
Kermanshah
Postal code
6632546412512
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
ir.kums.rec.1399.180
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Nausea
Timepoint
After three dialysis session
Method of measurement
VAS
Secondary outcomes
1
Description
temperature
Timepoint
Before and after each dialysis session
Method of measurement
Mercury thermometer axillary
2
Description
Feeling cold and chills
Timepoint
During dialysis
Method of measurement
Monitoring patient
Intervention groups
1
Description
Intervention group: The temperature of hemodialysis fluid (dialysate) is set at 36 ° C while the type of filter, filter ultrafiltration coefficient, and blood flow rate will not change.Patients in the intervention group will undergo dialysis with cold solution of 36 ° C for 3 times each week for 3-4 hours each time.
Category
Other
2
Description
Control group: The temperature of hemodialysis fluid (dialysate) is set at 37 ° C while the type of filter, filter ultrafiltration coefficient, and blood flow rate will not change. Patients in the control group will undergo dialysis with cold solution of 37 ° C for 3 times each week for 3-4 hours each time.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah
Full name of responsible person
yasem arghide
Street address
Kermanshah, Moallem town, end of Roudaki boulevard, Parstar boulevard - Imam Reza (AS) hospital
City
kermanshah
Province
Kermanshah
Postal code
67144-15333
Phone
+98 83 1839 4919
Email
info @ irhk.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd., Building No. 2, Deputy of Research and Technology
City
kermanshah
Province
Kermanshah
Postal code
6715561451
Phone
+98 83 3838 4185
Fax
+98 83 3837 0541
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah University of Medical Sciences Vice Chancellor for Research and Technology
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
Kermanshah University of Medical Sciences
Full name of responsible person
Yasem Arghide
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kermanshah - Isar Square - Dolatabad - School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3816 2532
Email
arghideyasem@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aliakbar Vaisi-Raygani
Position
Head of the School of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah - Isaar Square - Dolatabad - School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3816 2181
Email
visi_akbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yasem Arghide
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kermanshah - Isar Square - Dolatabad - School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3816 2181
Email
arghideyasem@yahoo.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
Yes - There is 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
Yes - There is 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
1- Study protocol 2- Study results
When the data will become available and for how long
After completing the study
To whom data/document is available
1- Faculty members 2- Clinical nurses 3- Medical and nursing students
Under which criteria data/document could be used
Access to data or documentation is possible for the following conditions: 1- Use in future study resources 2- Future studies