Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171023036953N1
Registration date: 2017-12-18, 1396/09/27
Registration timing: retrospective

Last update: 2017-12-18, 1396/09/27
Update count: 0
Registration date
2017-12-18, 1396/09/27
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 Sciences.
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cilostazol on the mean time of arteriovenous fistula maturation and its comparison to control group in patients with chronic renal failure referring to Emam Reza hospital of Mashhad University of Medical Sciences
Public title
The effect of Cilostazol on the mean time of arteriovenous fistula maturation and its comparison to control group in patients with chronic renal failure referring to Emam Reza hospital of Mashhad University of Medical Sciences.
Purpose
Prevention
Inclusion/Exclusion criteria
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.463

Health conditions studied

1

Description of health condition studied
renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
fistula maturation
Timepoint
3 weeks
Method of measurement
doppler sonography

Secondary outcomes

1

Description
fistula flow rate -distance from skin_vein diameter
Timepoint
3 weeks
Method of measurement
doppler sonography

Intervention groups

1

Description
Cilostazol was prescribed from the day of surgery at a dose of 50mg / day for two weeks, then continued 100mg / day for ten weeks or until fistula maturation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences.
Full name of responsible person
ALI SABERI
Street address
Azadi square , Mashhad University of Medical Sciences.
City
Mashhad
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
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
ALAVI HOSPITAL
Full name of responsible person
Dr Ali Saberi
Position
Vascular surgery fellowship
Other areas of specialty/work
Street address
Imam Reza street , 61th Ave, Alavi Hospital
City
Mashhad
Postal code
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
Vazsular surgery fellowship
Other areas of specialty/work
Street address
Alavi hospital
City
Mashhad
Postal code
Phone
+98 51 3851 3258
Fax
Email
alisaberi.md@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Ali Saberi
Position
Other areas of specialty/work
Street address
Alavi hospital of Mashhad University
City
Mashhad
Postal code
Phone
+98 51 3851 3258
Fax
Email
alisaberi.md@gmail.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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