Aims of this study are functional and complications comparison between two methods of hemodialysis catheter insertion( under fluoroscopic and traditional). Target sample size is established according to power 80% and confidence 95% and other studies 128 patients. In a randomized clinical trial with parallel plan,128 patients that have inclusion criteria after wisdom permission are allocated in two groups(under fluoroscopic and traditional). Randomizing process are doing by random blocs planning. Questionnaire is filled end of next day and 30th day after operation. Function and complications are compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120329181N3
Registration date:2016-12-25, 1395/10/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-25, 1395/10/05
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Modarres hospital
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical outcome comparison between two methods of blind and under flouoroscopic hemodialysis catheter insertion
Public title
Outcome and complications comparison between two methods of hemodialysis catheter insertion
Purpose
Prevention
Inclusion/Exclusion criteria
Patients that need hemodialysis and don't have any contraindication for surgery are recruited in this study.
Exclusion criteria: coagulopathy; uncontrolled cardiopulmonary disease that make patient unable to tolarate surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
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 Commity of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Danshju blvd., Velenjak
City
Tehran
Postal code
Approval date
2016-11-29, 1395/09/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.553
Health conditions studied
1
Description of health condition studied
Chronic kidney disease on hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Catheter function
Timepoint
First and 30th day
Method of measurement
Easily possibility of hemodialysis
Secondary outcomes
1
Description
Hematoma
Timepoint
During Insertion
Method of measurement
Physical Exam,Chest Radiography
2
Description
Pneumothorax
Timepoint
During Insertion
Method of measurement
Physical Exam,Chest Radiography
3
Description
Hemothorax
Timepoint
During Insertion
Method of measurement
Physical Exam,Chest Radiography
4
Description
Vessel Injury
Timepoint
During Insertion
Method of measurement
Physical Exam,Chest Radiography
Intervention groups
1
Description
In intervention group under fluoroscope at first the wire is navigated through internal jugular vein and park in IVC,then cahteter pass on the wire till cavoatrial junction.
Category
Treatment - Surgery
2
Description
In control group from internal jugular vein wire and catheter on the wire are navigated into SVC.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour Alamdari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Street address
Danshju Ave Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Modarres Hospital, Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2207 4087
Fax
Email
nassermalekpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Modarres Hospital, Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2207 4087
Fax
Email
nassermalekpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Modarres Hospital, Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
nassermalekpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)