Comparison of intravenous versus subcutaneous methods of erythropoietin injection on hemoglobin and hematocrit, complications and satisfaction of patients with Chronic kidney disease undergoing hemodialysis
Determining the effect of intravenous and subcutaneous injection of erythropoietin on hematocrit, hemoglobin, Systolic hypertension and satisfaction of injection method in patients with chronic kidney disease
Design
Quasi - experimental study before and after intervention without blindness (without independent control group).
Settings and conduct
Sampling was done among patients with chronic renal failure undergoing hemodialysis, referring to the hemodialysis department of Montsaray hospital in Mashhad,
available and non-blind. Evaluation of patients to enter the study
done through a research unit selection questionnaire.
The injection, for 4 months, was performed by the nurse after each session of the hemodialysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to speak persian language; hemodialysis three times a week;
Know the person, time and place; completely satisfactory cooperation; The patients are within the age limit of 18 - 60; Have Chronic kidney disease
; All subjects were given erythropoietin 3 times a week
exclusion criteria: Acute bleeding ; severe infection; uncontrolled
hypertension ; Pregnancy
Intervention groups
Subcutaneous erythropoietin 4000 units, Three times a week for two months and then for the same group, Intravenous erythropoietin 4000 units, Three times a week for another two months.
Its manufacturer is JANSSEN-CILGA Switzerland.
Main outcome variables
Hematocrit; Hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180124038491N1
Registration date:2018-12-28, 1397/10/07
Registration timing:retrospective
Last update:2018-12-28, 1397/10/07
Update count:0
Registration date
2018-12-28, 1397/10/07
Registrant information
Name
Azadeh Sheidaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 9275
Email address
sheidaeia1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-08-17, 1397/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous versus subcutaneous methods of erythropoietin injection on hemoglobin and hematocrit, complications and satisfaction of patients with Chronic kidney disease undergoing hemodialysis
Public title
Comparison of two methods of subcutaneous versus intravenous injection of Erythropoietin on hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have Chronic kidney disease
Hemodialysis is performed three times a week
Recieving Erythropoietin three times in a week
The patients are within the age limit of 18 - 60
Exclusion criteria:
Suffering from Cardiovascular disease
Recently, he has had acute bleeding.
Severe infection
Not satisfied with participation in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Not randomized
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 Mashhad University of Medical Sciences
Street address
Quraishi Building, Daneshgah Ave, Headquarters of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-04-20, 1397/01/31
Ethics committee reference number
IR.MUMS.REC.1397.049
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
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
Hematocrit
Timepoint
Measurement of hematocrit levels at the end of the first month and the second month in both methods
Method of measurement
Siys max device
2
Description
Hemoglobin
Timepoint
Measurement of Hemoglobin levels at the end of the first month and the second month in both methods
Method of measurement
Siys max device
Secondary outcomes
1
Description
patients Satisfaction
Timepoint
after tow month of intervention
Method of measurement
Satisfaction Questionnaire
Intervention groups
1
Description
The intervention group1:They will give 4000 units of erythropoietin three times a week for two consecutive months in subcutaneous form. At the end of each month, the hematocrit and hemoglobin levels will be measured. Its manufacturer is JANSSEN-CILGA, Switzerland, and the pharmaceutical companies of Oswah, and Iran's drug improvement
Category
Treatment - Other
2
Description
The intervention group 2:They will give 4000 units of erythropoietin three times a week for two consecutive months in Intravenous form. At the end of each month, the hematocrit and hemoglobin levels will be measured. Its manufacturer is JANSSEN-CILGA, Switzerland, and the pharmaceutical companies of Oswah, and Iran's drug improvement
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserie hospital
Full name of responsible person
Ali Asghar Yar Mohammadi
Street address
Opposite Saba Building, Imam Khomeini St. 25, mashhad, Razavi Khorasan Province.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137776788
Phone
+98 51 3229 1969
Fax
+98 51 3229 1960
Email
montaserie@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Quraishi Building, Daneshgah Ave, Headquarters of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
3316- 913791
Phone
+98 51 3841 2081
Fax
+98 51 3882 3251
Email
Tafaghodim@mums.ac.ir
Web page address
https://ict.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazloum
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Avicenna St., Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
mazlomr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazloum
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Avicenna St., Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3229 1970
Fax
+98 51 3859 7313
Email
Mazlomr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azadeh Sheidaie
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.15, West Eghbal Lahoory Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9115625890
Phone
+98 51 3502 9275
Fax
Email
sheidaeia1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD