Those hemodilaysis candidate patients with a brachiobasilic arteriovenous fistula because of the lack of suitable cephalic vein are included in this study after they meet the inclusion criteria. They will be undergone a basilic vein transposition surgery. In this operation, the basilic vein is totally released from beneath the deep fascia and proximity of the brachial artery and median nerve and transferred to the superficial subcutaneous space and lateralized at least 4 centimeter and fixed in this area. Follow-up is done in days 1,7,14 and 45 after the surgery for detecting the complications. Doppler flowmetery and evaluation for dialysability is done at day 45. The operation will be evaluated as "successful" if the vein could be cannulated by two access line and the patient could be dialysed for at least 4 hours with a 250 ml per minute flow for at leasts 3 sessions.
General information
Acronym
Basilic vein transposition in brachiobasilic arteriovenous fistulas
IRCT registration information
IRCT registration number:IRCT2014110716473N3
Registration date:2014-11-09, 1393/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-09, 1393/08/18
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice-chancellor of Tabriz University of medical sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the arm basilic vein transposition in brachiobasilic arteriovenous fistulas dialysability in chronic renal failure
Public title
Evaluation of the effect of the arm basilic vein transposition in brachiobasilic arteriovenous fistulas dialysability in chronic renal failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Brachiobasilic arteriovenous fistula for hemodialysis; minimum venous flow of 400 ml per minute; minimum venous diameter of 6 mm; no arterial steal syndrome; no venous hypertension; no significant skin lesion in the arm region; at least 2 months interval after the surgery; failure to access by the most experienced dialysis nurse at least for 3 times.
Exclusion criteria: venous flow less than 400 ml per minute; venous diameter less than 6 mm; fibrous changes of proximal basilic vein; less than 10 cm of releasable vein because of every reason; venous hypertension; steal syndrome; deformity of the arm; significant chronic or infectious skin lesion in the arm region; death in the follow-up period before the first dialysis attempt
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Golgasht St.
City
Tabriz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
5/4/10754
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
dialysability
Timepoint
45 days after the surgery
Method of measurement
By the dialysis nurse
2
Description
basilic vein blood flow difference
Timepoint
before and 45 days after the surgery
Method of measurement
by doppler sonography
3
Description
basilic vein diameter difference
Timepoint
before and 45 days after the surgery
Method of measurement
by doppler sonography
4
Description
length of releasable basilic vein
Timepoint
intraoperative finding
Method of measurement
by a ruler in centimeter
5
Description
maximum distance of basilic vein thrill from the skin incision
Timepoint
45 days after the surgery
Method of measurement
by a ruler in centimeter
Secondary outcomes
1
Description
patient's age
Timepoint
before the operation
Method of measurement
in years
2
Description
patient's gender
Timepoint
before the operation
Method of measurement
male or female
3
Description
cause of renal failure
Timepoint
before the operation
Method of measurement
by questionairre
4
Description
duration of the disease
Timepoint
before the operation
Method of measurement
by questionnaire in months
5
Description
circumference of the midforearm
Timepoint
before and 45 days after the operation
Method of measurement
with a tape in centimeter
6
Description
arterial steal syndrome
Timepoint
45 days after the operation
Method of measurement
by the surgeon according to history and physical exam
7
Description
venous hypertension
Timepoint
45 days after the operation
Method of measurement
by the surgeon according to history and physical exam
8
Description
bleeding
Timepoint
24 hours after the operation
Method of measurement
by the surgeon according to history and physical exam
9
Description
hematoma
Timepoint
24 hours after the operation
Method of measurement
by the surgeon according to history and physical exam
10
Description
wound infection
Timepoint
1,7,14 days after the operation
Method of measurement
by the surgeon according to history and physical exam
11
Description
nerve injury
Timepoint
1,7,14 days after the operation
Method of measurement
by the surgeon according to history and physical exam
12
Description
distal neuropathy
Timepoint
1,7,14 days after the operation
Method of measurement
by the surgeon according to history and physical exam
Intervention groups
1
Description
transposition (superficialization and lateralization) of arm basilic vein
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ahad Hasankhani
Street address
Surgery Ward
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice-chancellor of Tabriz University of medical sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor of Tabriz 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
Tabriz University of medical sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor of general and vascular surgery
Other areas of specialty/work
Street address
Surgery group, Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor/ General and vascular surgery
Other areas of specialty/work
Street address
Surgery group, Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor of general and vascular surgery
Other areas of specialty/work
Street address
Surgery group, Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)