Objective:
Finding a way to increase success rate of native AV fistula maturation is of great value and the aim of this study is to investigate whether Papaverine injection can improve maturation and success rate of AVF.
Design
This stud y is a clinical randomized trial that involved 110 patients with ESRD, referred for AVF construction.patients were divided into two equal groups and according to block randomization with random block size;
Settings and conduct
This study was a prospective clinical trial performed in vascular surgery clinic of Imam Reza’s hospital of Mashhad university of medical sciences, Mashhad, Iran. The study involved 110 patients with ESRD who referred by nephrologists requiring hemodialysis.For these patients, an arteriovenous fistula was constructed. Patients, an analyzer and a sonograhist did not know for which patients papaverin was injected.
Participants/Inclusion and exclusion criteria
The inclusion criteria was:
patients with ESRD who need hemodialysis and were suitable for AVF construction in distal upper limbs (snuff box and distal forearm) based on physical examination and Doppler sonography.
Exclusion criteria were:
diabetic patients,
patients with systolic blood pressure <120mm/hg during operation.
Previous history of AVF construction on their both upper limbs,
allergy to Papaverine.
Intervention groups
0.2-0.4 cc Papaverine (Papaverine Hcl 40mg/ml Exir med Inc.) injected with 30 gauge syringe within the subadventitia of artery and vein after proximal and distal control of artery and vein with bulldogs.
Main outcome variables
maturation time was 37.94days (SD=11.497) in papaverine group and 44.23 days (SD=9.572) in control group that was statistically significant(p=0.004).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171023036953N2
Registration date:2017-12-21, 1396/09/30
Registration timing:retrospective
Last update:2017-12-21, 1396/09/30
Update count:0
Registration date
2017-12-21, 1396/09/30
Registrant information
Name
ALI SABERI
Name of organization / entity
ALAVI hospital of mashhad university
Country
Iran (Islamic Republic of)
Phone
+98 51 3804 7205
Email address
alisaberi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
mashhad university of medical science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local Papaverine on arteriovenous fistula maturation
Public title
Effect of local Papaverine on arteriovenous fistula maturation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:patients with chronic renal failure that are candidate for hemodialysis with appropriate vascular anatomy for AVF creation
Exclusion criteria:
Exclusion criteria were: diabetic patients, patients with systolic blood pressure <120mm/hg during operation. Previous history of AVF construction on their both upper limbs, allergy to Papaverine. Patients put in two equal group (55 patients in each group) matched by age and sex.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
random block
Blinding (investigator's opinion)
Triple blinded
Blinding description
After matching for age and sex, patients were divided into two equal groups and according to block randomization with random block size; they allocated to each group of case or control.This was a triple blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Azadi square-Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2012-08-22, 1391/06/01
Ethics committee reference number
IR.MUMS.REC.1391.902
Health conditions studied
1
Description of health condition studied
RENAL FAILURE
ICD-10 code
N 18.5
ICD-10 code description
RENAL FAILURE
Primary outcomes
1
Description
Fistula maturation
Timepoint
Weekly for 3 weeks and then monthly for 3 monthes
Method of measurement
Doppler sonography and physical examination
Secondary outcomes
1
Description
Vein diameter,venous distance to skin,fistula flow rate
Timepoint
Weekly for 3 weeks and then monthly for 3 monthes
Method of measurement
Doppler sonography and physical examination
Intervention groups
1
Description
All patients underwent surgery with the same surgical team and one surgeon. Under local anesthesia with lidocain1 %[ Exir Medical Inc., Iran]. We used longitudinal incision about 3-5cm with sharp dissection with minimal manipulation of the vessels. We did
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Ali saberi
Street address
Azadi square-Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 3007
Email
alisaberi.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Saberi
Street address
Alavi hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3851 3258
Email
alisaberi.md@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
alavi hospital
Full name of responsible person
Dr Ali Saberi
Position
vascular surgeryfelowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Alavi hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3851 3258
Fax
Email
alisaberi.md@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
alavi hospital
Full name of responsible person
Dr Ali Saberi
Position
vascular surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Alavi hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3851 3258
Fax
Email
alisaberi.md@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Saberi
Position
Vascular surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Alavi hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 38513258
Fax
Email
alisaberi.md@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available