A comparative survey of efficiency of two type hemodialysis catheter with different medical factors in dailysis patient
Design
The study is a clinical trial. During one year, all dialysis patients, including 185 patients, were introduced to the Imam Center for continuous hemodialysis catheter insertion, which were randomly divided into two groups: catheter, Vector flow, and Palindrom. The phase of clinical trial in This current study does not apply. The intervention groups are random and can not be blinded.
Settings and conduct
For patients in the operating room, a surgeon underwent sonography of a continuous hemodialysis catheter in the internal jaguar vein and was followed up for one year and studied for duration and length of life.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent of patients and patients undergoing hemodialysis candidate dialysis;
Exclusion Criteria: non-cooperation for follow-up
Intervention groups
In this study, the patients were divided into two groups and one group of catheter Vector flow and the other group were placed in the catheter of the Palindrome and compared with the catheter longevity
Main outcome variables
Lifetime of hemodialysis catheter, The effect of individual factors on catheter longevity, spent costs, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038837N2
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Mohammad Reza Sobhiyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6333
Email address
mohammadreza.sobhieh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-09-23, 1397/07/01
Scientific title
A comparative Survey of efficacy of two type hemodialysis catheter with different medical factors in dailysis patient
Public title
Efficiency of two type hemodialysis catheter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All dialysis patients who are candidates for hemodialysis
Exclusion criteria:
Failure to collaborate for follow-up
Age
From 27 years old to 94 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
185
Actual sample size reached:
185
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 185 patients with entry conditions are selected by available sampling method and then randomly assigned randomly using the random numbers table in one of the two groups of vector flow and palindrom
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
The Effect of Individual Characteristics on Catheter Longevity
Timepoint
One year
Method of measurement
Documentation file
Intervention groups
1
Description
Intervention group 1: This group consists of patients who have been placed in a catheter with a vector flow. The catheter is a continuous hemodialysis catheter inserted in the operating room by the surgeon and under sonography in the jaguar vein.
Category
Treatment - Surgery
2
Description
Intervention group 2: This group consists of patients who have been placed under the patch catheter. The palindrome catheter is a permanent hemodialysis catheter that is inserted into the operating room by the surgeon in the jaw gland ultrasound in the jaguar vein.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammadreza Sobhieh
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6301
Email
admin@irhk.ir
Web page address
http://www.irhk.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Administrative building of Kermanshah University of Medical Sciences,Shahid Beheshti Blvd.,Kermanshah.City,Iran
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3837 0541
Email
Farid_n32@yahoo.com
Web page address
http://www.irhk.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
Mohammadreza Sobhieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 988334276333
Email
mreza.sobhieh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadreza Sobhieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Email
mreza.sobhieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadreza Sobhieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Email
mreza.sobhieh@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the case of the participants data file,three months after the publication of the article,and after unidentification of the persons,the request can be sent by email
When the data will become available and for how long
Three months after the publication of the article,upon request by email,there is a possibility to post
To whom data/document is available
Only scholars working in academic and scientific institutions
Under which criteria data/document could be used
The name of the first author of the study is required in an extracted article from the study data.In this case,it is possible to perform any statistical analysis
From where data/document is obtainable
Correspondence by email with the Doctor Mohammadreza Sobhieh.Email:mreza.dobhieh@yahoo.com
What processes are involved for a request to access data/document
Up to one week after receipt of the email,tge requested documentation is sent