Objective: comparative evaluation of the complications of closure and not closure vein distal in snuff box AVFs in chronic renal failure patients. Design of the study: randomization using random permuted blocks, convenience sampling, double-blind, single-center, phase II trial. Study population: all patients with stage 5 of renal failure. Main inclusion criteria: patients who are followed for up to 7 months after surgery; No blood sampling or blood pressure measurement of the limb which will be chosen for fistula. Main exclusion criteria: systolic blood pressure below 100 mm Hg; positive history of subclavian catheter placement of the aimed limb; the absence of thrill and machinery murmur after the operation; hemodialysis stop due to recovery or transplantation or death. Sample size: 60. Interventions: closure the distal of the vein after AV fistula surgery in intervention group. In control group, not closure the distal of the vein after AV fistula surgery. Intervention time: at the time of arteriovenous fistula placement during operation. Outcomes of interest: early efficacy of arteriovenous fistula, late efficacy of arteriovenous fistula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111030819N1
Registration date:2017-01-23, 1395/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-23, 1395/11/04
Registrant information
Name
Jalal Seyyedi
Name of organization / entity
Zahedan Medical University of Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5721
Email address
drseyyedi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison the complications of closure and not closure distal of the vein in snuff box AVFs in chronic renal failure patients
Public title
Comparison the complications of closure and not closure distal of the vein in snuff box AVFs in chronic renal failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: patients who are followed for up to 7 months after surgery; No blood sampling or blood pressure measurement of the limb which will be chosen for fistula. Main exclusion criteria: systolic blood pressure below 100 mm Hg; positive history of subclavian catheter placement of the aimed limb; the absence of thrill and machinery murmur after the operation; hemodialysis stop due to recovery or transplantation or death.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.zaums.rec.1394.264
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N18, N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Early efficacy of venous fistula
Timepoint
One day and one month after surgery
Method of measurement
A palpable thrill and bruit hearing
2
Description
Late efficacy of venous fistula
Timepoint
Three months after surgery
Method of measurement
Palpable thrill and bruit hearing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Closure the distal of the vein after AV fistula surgery
Category
Treatment - Surgery
2
Description
Control group: not closure the distal of the vein after AV fistula surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Jalal Seyyedi
Street address
Surgery Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Jalal Seyyedi
Position
Surgery Residence
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Blvd, Dr.Hesabi Sq., Daneshgah Ave., Zahedan