A comparative study on the efficiency of Drug-coated balloon with non-medicinal balloon in the efficiency of intravenous artery fistula in hemodialysis patients over a six-month period
A comparative study on the efficiency of the Drug-coated balloon with non-medicinal balloon in the efficiency of intravenous artery fistula in hemodialysis patients over a six-month period
Design
This study is a non-blinded clinical trial. The study population will be included all patients with chronic renal failure refer to Imam Reza hospital of Kermanshah city.50 eligible patients will be selected conveniently and randomly will be assigned to two intervention groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is non-blinded one. At the beginning of the study, blood pressure is recorded in a checklist in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic renal failure
Exclusion criteria: Patients who there is no possibility of fistulate during surgery for them
Intervention groups
In the first intervention group, surgery is performed through an angioplasty medicinal balloon.
Main outcome variables
Blood pressure, infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N112
Registration date:2019-02-19, 1397/11/30
Registration timing:retrospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the efficiency of Drug-coated balloon with non-medicinal balloon in the efficiency of intravenous artery fistula in hemodialysis patients over a six-month period
Public title
Comparison of the efficiency of the Drug-coated balloon with non-medicinal balloon in the efficiency of the intravenous artery fistula in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic renal failure
Exclusion criteria:
Patients who there is no possibility of fistulate during surgery for them
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
ir.kums.rec.1397.518
Health conditions studied
1
Description of health condition studied
Patients who are treated with hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Renal Failure
Primary outcomes
1
Description
Blood pressure
Timepoint
The day after surgery, one week later and 3 weeks later
Method of measurement
using blood pressure measurement
2
Description
Infection
Timepoint
The day after surgery, one week later and 3 weeks later
Method of measurement
By the doctor
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, surgery is performed through an angioplasty balloon. In the second intervention group, surgery will be performed through non-pharmacological angioplasty.
Category
Treatment - Surgery
2
Description
In the second intervention group, surgery will be performed through non-pharmacological angioplasty.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital, Parastar Boulevard
Full name of responsible person
Siroos Amiri
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
siroosamiri1348@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Siroos Amiri
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
siroosamiri1348@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
ِDr. Mohammd reza Sobhiyeh
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mreza.sobhiyeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Siroos Amiri
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
siroosamiri1348@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail