Determining the effect of educational care educational intervention on the adequacy and prevention of complications during hemodialysis
Design
A clinical trial with a control group, a blind strain, on 88 patients, which will be conducted by lottery in the form of single or double visits.
Settings and conduct
Research location: Dialysis center of Imam Hossein (AS) hospital, Malayer city.
The samples are divided into two intervention groups (visitors on even or odd days) and the control group (visitors on even or odd days) which are selected through lottery and blinding will be in the field of statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age above 18 years
Absence of mental problems, blindness, deafness
Not having a history of known muscle diseases
Hemodialysis 3 times a week, duration of dialysis 3:30 and more
Exclusion criteria:
Clotting of the patient's blood during dialysis
Blood transfusion during hemodialysis
Receiving medication for low blood pressure and muscle cramps
Intervention groups
Control group: completion of demographic information questionnaire and examination of hemodialysis complications and hemodialysis adequacy.
intervention group:
1: Training on diet and taking personal medications and weight control between dialysis sessions
2: Use of sodium profile and ultrafiltration profile and temperature profile during hemodialysis
3: Set ultrafiltration to a maximum of 13cc/kg/h
4: Lower limb priority in case of blood pressure less than 90 mm Hg
5: Lower massage in the third hour of dialysis
6: Taking 5 cc blood samples before and after dialysis to measure hemodialysis adequacy
Main outcome variables
Blood pressure drop, adrenal congestion, adequacy of hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231010059684N1
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Kazem Keyhanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
k.keyhanfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-26, 1402/09/05
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care educational intervention on the adequacy and complications during hemodialysis
Public title
The effect of care educational intervention on the adequacy and complications during hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to cooperate and participate in research
Age above 18 years
Hemodialysis 3 times a week
The duration of dialysis is 3:30 and more
Exclusion criteria:
Receiving medication for low blood pressure and muscle cramps
Having a history of known muscle diseases
Having mental problems, blindness, deafness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, blinding will be done only in the context of the statistical analyst, in such a way that the statistical analyst will not be aware of the allocation of patients in the intervention and control groups, and the control and intervention groups will be marked with a code of one and two, so that only the researcher from the control group and have knowledge of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Behorzi Education Center, Behir Alley, Sohrab Zand Street
City
Hamedan
Province
Hamadan
Postal code
6573139435
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.ARAKMU.REC.1402.139
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
blood pressure less than 90 mm Hg during hemodialysis
Timepoint
Measurement of blood pressure drop in the first, second and third hours of dialysis.
Method of measurement
Mercury sphygmomanometer
2
Description
muscle cramps during hemodialysis.
Timepoint
Measuring the occurrence of muscle cream in the first, second and third hours of dialysis
Method of measurement
check list
3
Description
adequacy of hemodialysis
Timepoint
Measurement of hemodialysis adequacy before and after intervention
Method of measurement
Daggerdas formula
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:1: Training on diet and taking personal medications and weight control between dialysis sessions2: Use of sodium profile and ultrafiltration profile and temperature profile during hemodialysis3: Set ultrafiltration to a maximum of 13cc/kg/h4: Lower limb priority in case of blood pressure less than 90 mm Hg5: Lower massage in the third hour of dialysis6: Taking 5 cc blood samples before and after dialysis to measure hemodialysis adequacy
Category
Prevention
2
Description
Control group: Control group: In the control group, no care training will be given. This group will undergo dialysis according to the normal routine, and 5 cc of blood will be taken before and after dialysis to measure the adequacy of dialysis.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Malayer Hospital
Full name of responsible person
Keyhanfar Kazem
Street address
Imam Hossein Hospital, Nurse Street
City
Malayer
Province
Hamadan
Postal code
6571961441
Phone
+98 81 3222 0001
Email
Imamhossein_hosp@umsha.ac.ir
Web page address
https://imamhossein-hosp.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Arak University of Medical Sciences
Street address
Alam El Hadi St., Khilban Shahid Shiroudi
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
it@arakmu.ac.ir
Web page address
https://www.arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Keyhanfar Kazem
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behorzi Education Center, Behiyar Alley, Sohrab Zand St
City
Malayer
Province
Hamadan
Postal code
6573139435
Phone
0098 81 2411755
Email
K.keyhanfar@Arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamdani Behzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
Hamedanibehzad166@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
keyhanfar Kazem
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Hossein Hospital
City
Malayer
Province
Hamadan
Postal code
6517953371
Phone
0098 81 2411755
Email
K.keyhanfar@Arakmu.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