A comparison between the primary patency time of prosthetic arterio venous access graft(6mm) and prosthetic arterio venous access graft (4-7mm)in hemodialysis patients
The objective of this randomized trial is to investigate the primary patency time of two diffrent types prosthetic brachioaxillary access grafts in hemodialysis patients. In this study, 30 hemodialysis patients who meet the inclusion /exclusion criteria will be recruited and randomly assigned in to intervention or control group. The patients in two intervention groups will be operated for arteriovenous bypass graft(6mm)or arteriovenous bypass graft (4-7mm)and the duration of suitable performance of created hemodialysis access will be recorded as primary patency time and will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211045633N2
Registration date:2013-04-06, 1392/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-06, 1392/01/17
Registrant information
Name
Mahdi Davoudi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1225 6329
Email address
mdavoudi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research affairs Mazandaran University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the primary patency time of prosthetic arterio venous access graft(6mm) and prosthetic arterio venous access graft (4-7mm)in hemodialysis patients
Public title
A comparison the primary patency time between the two types of grafts in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:no history of previous AVG;do not use anticoagulant drugs
exclusion criteria:previous AVG;using anticoagulant drugs
Age
From 30 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vice chancellor of research affairs, Moalem square, Sari
City
Sari
Postal code
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
91-133
Health conditions studied
1
Description of health condition studied
progressive renal failure
ICD-10 code
N18.0
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
primary patency time
Timepoint
2weeks, 1month, 2months, 3months, 6months, after every 3months to years after surgerys
Method of measurement
doppler sonography, examination
Secondary outcomes
1
Description
symptoms of thrombosis(pain,redness,swelling)
Timepoint
2weeks,1month,2months,3months,6months,after every 3months to2 years after surgery
Method of measurement
examination,observation
2
Description
thrill in embedded pathway
Timepoint
2weeks,1month,2months,3months,6months,after every 3months to2 years after surgery
Method of measurement
examination,observation
3
Description
symptoms of infection(pain,redness,swelling)
Timepoint
2weeks,1month,2months,3months,6months,after every 3months to2 years after surgery
Method of measurement
examination,observation
Intervention groups
1
Description
Operation to create hemodialysis access for arteriovenous graft including exploration of brachial artery and axillary vein and pass the graft 6 mm from subcutaneous area of arm and then vascular anastomosis in proximal side with axillary vein and in distal side with brachial artery.
Category
Treatment - Surgery
2
Description
Operation to create hemodialysis access for arteriovenous graft including exploration of brachial artery and axillary vein and pass the graft(4-7mm) from subcutaneous area of arm and then vascular anastomosis in proximal side with axillary vein and in distal side with brachial artery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Vascular Surgery Clinic at Imam Khomeini Hospital
Full name of responsible person
Dr. Azadeh Beheshtian(Resident of General Surgery)
Street address
Imam Khomeini Hospital, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences vice chancellor of research
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sacines Vice Chancellor of Research affairs, Moalem square, sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences vice chancellor of research
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Beheshtian
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Department of General surgery at Imam khomeini Hospital-sari
City
Sari
Postal code
Phone
+98 21 7747 2238
Fax
Email
abeheshtian2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Beheshtian
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Department of General Surgery at Imam khomeini Hospital-sari
City
sari
Postal code
Phone
+98 21 7747 2238
Fax
Email
abeheshtian2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Beheshtian
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Department of General Surgery at Imam khomeini Hospital -sari
City
Sari
Postal code
Phone
+98 21 7747 2238
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)