The survey of the effect of cool dialysate on hemodynamic condition and adequacy of dialysis in hemodialysis patients in Razi hospital, Rasht, Iran, 2019
The aim of this study was to find an effective relationship between reducing dialysis temperature and hemodynamic status during dialysis and the adequacy of dialysis and providing a basis for easier dialysis process and better outcome for hemodialysis.
Design
This is a pre and post quasi experimental study that will be performed on 99 dialysis patients who will be selected by simple sampling. This study was done with the method of before and after on the same patients and did not have a control group.
Settings and conduct
This research is done in dialysis unit of Razi Hospital in Rasht.
Patients are subjected to dialysis in three consecutive sessions at 37 ° C. Blood pressure and pulse are measured and recorded before, during and after each dialysis. At the beginning and end of the third session, the BUN blood sample is taken to calculate the adequacy of dialysis.
In the next step, these patients undergo dialysis in three consecutive sessions with a temperature of 35.5 ° C and the values of the variables are measured and recorded in the previous method.
Participants/Inclusion and exclusion criteria
Entry requirements: patients undergoing hemodialysis three times a week, history of hemodialysis at least three months before the study, not having cardiovascular disorders, not having thyroid disorders, and willingness to participate in the study.
Exit conditions: severe shivering, severe cardiovascular events such as unstable angina pectoris or heart attacks during dialysis, Severe hypotension and unwillingness to continue cooperation.
Intervention groups
We use dialysis solution at 37 ° C and 35.5 ° C for hemodialysis for patients and compare the hemodynamic stability during dialysis and dialysis adequacy in two temperatures.
Main outcome variables
Measurable consequences include systolic blood pressure, diastolic blood pressure, pulse, and dialysis adequacy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080825001083N9
Registration date:2019-05-24, 1398/03/03
Registration timing:prospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Majid Pourshaikhian
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 5768
Email address
m_pourshaikhan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the effect of cool dialysate on hemodynamic condition and adequacy of dialysis in hemodialysis patients in Razi hospital, Rasht, Iran, 2019
Public title
The survey of the effect of cool dialysate on hemodynamic condition and adequacy of dialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis patients undergoing hemodialysis three times a week
History of hemodialysis at least three months before the study
The desire to participate in the study
Exclusion criteria:
Cardiovascular Disease
Thyroid Disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of medical sciences
Street address
Namjo Blv - Shahid Ansari street - Facing the 17 Shahrivar hospital
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.GUMS.REC.1398.071
Health conditions studied
1
Description of health condition studied
CKD
ICD-10 code
I13.11
ICD-10 code description
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Systolic blood pressure changes
Timepoint
Initially, during and after dialysis at each stage of hemodialysis
Method of measurement
Digital manometer
2
Description
Diastolic blood pressure changes
Timepoint
Initially, during and after dialysis at each stage of hemodialysis
Method of measurement
Digital manometer
3
Description
Heart rate changes
Timepoint
Initially, during and after dialysis at each stage of hemodialysis
Method of measurement
Digital manometer
4
Description
Adequacy of dialysis
Timepoint
First and the end of third turn of dialysis at two different temperatures
Method of measurement
Measuring blood BUN and calculating based on Daugirdas-II formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is done with a sample size of 99 dialysis patients from Razi Hospital who will be selected by simple sampling method. These patients will undergo dialysis with the same dialysis solution for the compounds in them, the same dialysis filters will be dialyzed at each dialysis for each patient and at the same time each time. Initially, each patient undergoes hemodialysis in three consecutive sessions with a dialysis solution of 37 ° C which is the usual temperature for dialysis and is currently used for this hemodialysis temperature at this center. Blood pressure and pulse of the patient Before each dialysis, during (2 hours after the start of dialysis ) and immediately after each dialysis is monitored and recorded. The patient's blood sample is taken to carry out the BUN test before and after the third dialysis so that its results can be used to measure the adequacy of dialysis. In the next three sessions of dialysis, the patient undergoes hemodialysis with a cold dialysis solution at 35.5 ° C, and as before, blood pressure and pulse rates were recorded before, during and after each dialysis, and in the third dialysis, Before and after dialysis, the patient's blood sample is taken for BUN testing. Diastolic and diastolic blood pressure, and the number of pulses recorded at each turn of dialysis, will be used to calculate the mean of these values as well as the difference in mean values at 35.5 ° C and 37 ° C. To monitor patients during dialysis, hemodynamic monitoring and recording, as well as blood sample collection, will be used by one experienced nurse in the dialysis unit as a collaborator. Blood samples taken at two different temperatures are labeled with their number and temperature. After receiving the test responses, the dialysis adequacy ratio (KT / V) for each temperature is calculated and recorded using the formula for the ratio of time clearances to the volume of urea release (KT / V). To calculate KT / V, a computer software that will calculate it based on the Daugirdas II logarithmic formula will be used. To control systolic blood pressure, diastolic blood pressure and pulse rate, the OMRON digital barometer, the Japan-based manufacturing model M3, which is one of the most prominent brands in Iran, will be used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi eductional & theraputic center
Full name of responsible person
Majd Pourshaikhian
Street address
Razi eductional & theraputic center, Sardare jangal Ave,
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3355 0028
Email
pourshaikhian_m@yahoo.com
Web page address
http://www.gums.ac.ir/razi
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Abdorrasool Sobhani
Street address
Namjo Blv - Siadati Ave
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3336 2842
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Majid Pourshaikhian
Position
MSc of anesthesia/ Faculty member of group of anesthesia ofGuilan University of Medical Sciences and
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi eductional & theraputic center, Sardare jangal Ave,
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 135540415
Fax
+98 13 3355 9787
Email
m_pourshaikhan@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Majid Pourshaikhian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice-chancellor for Research, Guilan University of Medical Sciences and Health Services, Shahid Sia
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3360 5768
Fax
+98 13 3355 0097
Email
m_pourshaikhan@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Majid Pourshaikhian
Position
MSc of anesthesia/ Faculty member of group of anesthesia ofGuilan University of Medical Sciences and
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi eductional & theraputic center, Sardare jangal Ave,
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 1554 0415
Fax
+98 13 3355 9787
Email
m_pourshaikhan@gums.ac.ir
Web page address
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
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
Title and more details about the data/document
The final outcome of the study can be shared for all dialysis patients and other people who have a job relationship with these patients. The total potential data can be shared for researchers and students of medical and paramedical groups after unidentifiable individuals.
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Dialysis patients, Researchers and students of medical and paramedical groups, Academic and Private Institutions
Under which criteria data/document could be used
The results of the research do not appear to be applicable to non-medical individuals and private companies. However, if necessary, they can contact the researcher of this research (Dr. Majid Pourshikihian) at 00989113304288 or email : pourshaikhian_m@yahoo.com.
From where data/document is obtainable
Dr.Majid Pourshaikhian - Nursing and Midwifery Faculty of Rasht - 00989113304288 - E-mail : pourshaikhian_m@yahoo.com
What processes are involved for a request to access data/document
This research is in the form of student dissertation.Therefore,to receive official information and documentation, please contact the Delegation of the Nursing and Midwifery Faculty of Rasht.
To speed up the correspondence process, you can contact the researcher (Dr. Majid Pourshikihan) at (00989113304288) or E-mail : pourshaikhian_m@yahoo.com