Protocol summary

Study aim
Determining the rate of reduction of infection with vancomycin before semi-permanent catheterization in 1399 in Golestan Hospital
Design
The study was performed as a randomized double-blind clinical trial based on a random number table. Patients with chronic renal failure admitted to the nephrology ward of Ahvaz Golestan Hospital who need dialysis and hemodialysis dual catheter installation are examined.
Settings and conduct
The study was conducted as a randomized double-blind clinical trial based on a random number table. Patients with chronic renal failure admitted to the nephrology ward of Ahvaz Golestan Hospital who require dialysis and installation of a double-sided hemodialysis catheter are examined. The intervention group receives one gram of vancomycin antibiotic by intravenous injection one hour before catheterization. The control group receives normal saline in the same volume by a person who is not aware of the research. The patient and the people evaluating the final outcomes have no knowledge of grouping the people into the intervention and control groups.
Participants/Inclusion and exclusion criteria
- Patient with ESRD - Not using antibiotics before the study - Sterile conditions during catheter installation - Lack of evidence of infection in other parts of the body - Satisfaction to participate in the study
Intervention groups
To evaluate the effect of vancomycin antibiotic before semi-permanent catheterization to prevent catheter-dependent infection, the intervention group received one gram of vancomycin antibiotic by intravenous injection and normal saline with the same volume one hour before catheterization.
Main outcome variables
The main outcome variables in this study included reviewing and comparing the incidence of catheter related infection over a period of 6 months; The time of the catheter related infection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201206049617N1
Registration date: 2020-12-15, 1399/09/25
Registration timing: registered_while_recruiting

Last update: 2020-12-15, 1399/09/25
Update count: 0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Zohreh Zandbaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
farajzadeh_h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of single dose prophylactic vancomycin before semi-permanent catheterization to prevent catheter related infection: Randomized Controlled Trial, Phase 2
Public title
To evaluate the effect of single dose prophylactic vancomycin before semi-permanent catheterization to prevent catheter related infection: Randomized Controlled Trial, Phase 2
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patient with ESRD Not using antibiotics before the study sterile conditions during catheter installation Lack of evidence of infection in other parts of the body Satisfaction to participate in the study
Exclusion criteria:
No end-stage renal disease or no need to install a catheter for dialysis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on the method of 4 random block permutations. The site sealedenvelope.com Randomization section under Creat a List section was used to generate a randomization sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, physicians, nurses, data collectors, those assessing the consequences, and the Safety and Data Monitoring Committee were kept blind. In order to eliminate the bias caused by the knowledge of them, the results are based on the type of treatment received and its possible impact on the research result of the study in a double-blind manner. Similar vials were used for vancomycin and placebo, and randomization was performed by sealedenvelope.com, according to which each patient was placed in the treatment or control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapur Medical Sciences
Street address
Ahvaz Jondishapur Medical Sciences, Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.106

Health conditions studied

1

Description of health condition studied
Catheter related infection
ICD-10 code
T82.7XXA
ICD-10 code description
Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts, initial encounter

Primary outcomes

1

Description
Incidence of catheter-dependent infection
Timepoint
6 months
Method of measurement
Blood culture, Catheter lumen culture and signs of infection including fever and purulent discharge from the catheter site

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with end-stage renal disease receive one gram of the vancomycin antibiotic by intravenous injection one hour before the implantation of a semi-permanent catheter.
Category
Prevention

2

Description
Control group: Patients with end-stage renal disease receive normal saline by intravenous injection one hour before catheterization.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Meyssam Moezzi
Street address
Golestan Hospital, Golestan ave
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
golestanjpspital@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zohreh Zandbaf
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Golestan ave
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
farajzadeh_h@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zohreh Zandbaf
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Golestan ave
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
farajzadeh_h@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zohreh Zandbaf
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Golestan ave
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
farajzadeh_h@ajums.ac.ir

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
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