Protocol summary

Summary
Radiocephalic arteriovenous fistula (AVF) at wrist is the vascular access of choice for dialysis. In the absence of a suitable vein at the wrist, a brachiocephalic fistula at elbow is usually constructed.we in this study according to position and excellency of utilization of Proximal Radial Artery , we in thise study124 patiant who candidate for creation of arteriovenous fistula in the antecubilal region divided in two group,and in one group use brachial artery and in another group use proximal radial artery then compare this two artery in creation of vascular access for dialysis acordinig to incidense of primary failure,complication and time of maturation .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041012973N1
Registration date: 2013-09-04, 1392/06/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-04, 1392/06/13
Registrant information
Name
Amirreza Naimi
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 1041
Email address
naimi-a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
sina trauma&surgery research center,sina hospital,hasan abad Sq.,Tehran,Iran
Expected recruitment start date
2013-08-20, 1392/05/29
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of proximal radial artery to brachial artery in creation of arteriovenous fistula for hemodialysis
Public title
metod of creation of arterio venous fistula for dialyse
Purpose
Treatment
Inclusion/Exclusion criteria
cronic renal failure patiant who candidate for creation of arteriovenous fistula in the antecubital area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Not 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
sina trauma&surgery research center
Street address
sina hospital,hasan abad Sq.,Tehran,Iran
City
tehran
Postal code
Approval date
2011-10-12, 1390/07/20
Ethics committee reference number
421/10600187

Health conditions studied

1

Description of health condition studied
vascular access in cronic renal failure
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
incidence of complication after creation of arteriovenouse fistula as steal syndrom,primary dysfunction
Timepoint
evry 2 week until 3month
Method of measurement
physical examination

2

Description
period of maturation of fistula after creation
Timepoint
evry 2 week until maturation
Method of measurement
physical examination

Secondary outcomes

1

Description
steal syndrom,failure
Timepoint
evry 2 week until 3 month
Method of measurement
physical examination

Intervention groups

1

Description
Brachial artery (rotine metod) choosed for creation of arteriovenouse fistula
Category
Treatment - Surgery

2

Description
proximal radial artery choosed for creation of arteriovenouse fistula
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
sina hospital
Full name of responsible person
amirreza naimi
Street address
emam khomeyni st. sina H.
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
SinaTtrauma&Surgery research center
Full name of responsible person
Amirrezanaimi
Street address
Sina Hospital, Emam khomeyni St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
SinaTtrauma&Surgery research center
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
sina trauma&surgery research center
Full name of responsible person
amirreza naimi
Position
floship of vascular surgery
Other areas of specialty/work
Street address
sina H.
City
tehran
Postal code
Phone
+216 6348523
Fax
Email
naimi-a@arakmu.ac.iramirrezanaimi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
sina trauma&surgery research center
Full name of responsible person
amirreza naimi
Position
floship of vascular surgery
Other areas of specialty/work
Street address
sina H.
City
trhran
Postal code
Phone
+98 21 6634 8523
Fax
Email
amirrezanaimi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
sina trauma&surgery research center
Full name of responsible person
amirreza naimi
Position
floship of vascular surgery
Other areas of specialty/work
Street address
sina H.
City
tehran
Postal code
Phone
+98 21 6634 8523
Fax
Email
amirrezanaimi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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