Comparison of prevalence of cardiac arrhythmias during dialysis in dialysis group with standard temperature of 37 ° C and dialysis group with temperature of 36 ° C.
Comparison of hemodynamic status in dialysis group with standard temperature of 37 °C and dialysis group with temperature of 36 °C
Design
This study is a single-blind crossover clinical trial in patients undergoing hemodialysis. A total of 35 patients were selected using the available method. Each sample participated in the study twice.
Settings and conduct
Each sample participated in the study twice. Patients were dialysed for one month with dialysate temperature at 37 ° C and one month (second time) with dialysate temperature at 36 ° C. The observer is blind to the type of intervention.
Participants/Inclusion and exclusion criteria
-The patient must be at least 18 years of age
- Patients have undergone hemodialysis at least 3–6 months prior to the study
-Patients have not received antiarrhythmic drugs (inotropic, Digoxin, Beta blockers, etc.(.
- The patient's blood pressure should not exceed 150/100 mmHg.
-The patient death
-Lack of desire to continue to participate in the study
- Intolerance to cold dialysate (in case of severe chills)
- If the patient's blood pressure rises, 30mmHg higher than the initial blood pressure or becomes more than 170mmHg
Intervention groups
Dialysate temperature with 36 ° C in intervention group
Dialysate temperature with 37 ° C in control group
Main outcome variables
The prevalence of cardiac arrhythmias ; hemodynamic status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N16
Registration date:2020-02-06, 1398/11/17
Registration timing:retrospective
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold dialysate on the prevalence of cardiac arrhythmias and hemodynamic status during dialysis
Public title
The effect of cold dialysate on the prevalence of cardiac arrhythmias and hemodynamic status during dialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have been under hemodialysis for at least 6- 3 months prior to the study
Patients have not received antiarrhythmic drugs (inotropic, digoxin, beta blockers, etc.).
The patient's blood pressure should not exceed 150/100 mmHg
Exclusion criteria:
Patient death
Unwillingness to continue participating in the study
Intolerance to cold dialysis solution (if it is severe chills)
In the event of an increase in blood pressure, the patient will have 30mmHg more than the baseline or greater than 170mmHg
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Reviews of arrhythmias are blind to the intervention.
Placebo
Not used
Assignment
Crossover
Other design features
In this study, patients were studied in two hemodialysis courses. The first period of one month is hemodialysis with dialysate at a standard temperature of 37 ° C. The second period is dialysed with a dialysate (36 ° C) for one month.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717676563
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.RUMS.REC.1397.164
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Percentage of arrhythmias during hemodialysis
Timepoint
Since the beginning of hemodialysis to an hour after dialysis
Method of measurement
Central Monitor,Holter monitoring
2
Description
hemodynamic status (Blood pressure, heart rate, respiratory rate, temperature)
Timepoint
Since the beginning of hemodialysis to an hour after dialysis
Method of measurement
Central Monitor
Secondary outcomes
1
Description
Stability of cardiovascular status during dialysis
Timepoint
Since the beginning of hemodialysis to an hour after dialysis
Method of measurement
central monitor، Holter monitoring
Intervention groups
1
Description
Intervention group: Dialysate is a pharmed pharmacy company that contains sodium, potassium, magnesium, calcium and bicarbonate ions at temperatures of 36 ° C.
Category
Treatment - Drugs
2
Description
Control group: Dialysate is a pharmed pharmacy company that contains sodium, potassium, magnesium, calcium and bicarbonate ions at temperatures of 37 ° C.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alibn Abi Talb hospital
Full name of responsible person
Dr.Majid Kazemi
Street address
Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
Maj_kaz@yahoo.com
Web page address
https://rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Majid Kazemi
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717676563
Phone
+98 34 3428 0038
Email
Dr.kazemi.n@rums.ac.ir
Web page address
https://rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Forozande Vatanparast
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar
City
Rafsanjan
Province
Kerman
Postal code
7718754233
Phone
+98 34 3425 5900
Fax
+98 34 3425 5900
Email
forozanvatan96@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Majid kazemi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Moddares
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 5900
Email
Maj_kaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences.Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717676563
Phone
+98 34 3428 0038
Fax
+98 34 3425 8497
Email
Maj_kaz@yahoo.com
Web page address
https://rums.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
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