Comparative study of the effect of Heparin alone or in combination with Amikacin and Vancomycin antibiotics in the prevention of infection caused by tunnel central catheters in patients with renal insufficiency undergoing hemodialysis
Comparison of the effect of heparin alone or in combination with vancomycin and amikacin antibiotics topically in the prevention of infection caused by tunnel central catheters in patients with renal failure undergoing hemodialysis
Design
Clinical trial with parallel, double-blind, randomized groups based on random number table, phase 2 on 60 patients with end-stage renal disease undergoing hemodialysis with tunnel central catheter
Settings and conduct
60 patients with end-stage renal failure who are undergoing chronic hemodialysis with a central tunneled catheter are divided into two groups A and B. Double-blinding will be performed, so that the patient and the researcher responsible for data entry will be unaware of the intervention performed. For groups A and B, respectively, heparin alone and heparin in combination with vancomycin and amikacin were used locally, and during a six-month follow-up, the rate of infection caused by the catheter will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: End-stage renal failure patients undergoing chronic hemodialysis with a tunneled central catheter. Exclusion criteria: Antibiotic use in the previous two weeks.
Intervention groups
Intervention group: Heparin (5000 units/ml) plus Vancomycin (500 mg) and local Amikacin (500 mg) antibiotics in the catheter lumen; Control group: Heparin (5000 units/ml) in the catheter lumen
Main outcome variables
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210317050735N1
Registration date:2023-01-04, 1401/10/14
Registration timing:prospective
Last update:2023-01-04, 1401/10/14
Update count:0
Registration date
2023-01-04, 1401/10/14
Registrant information
Name
MARYAM IRANIKIA
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 2886
Email address
dr.maryam.1983@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of Heparin alone or in combination with Amikacin and Vancomycin antibiotics in the prevention of infection caused by tunnel central catheters in patients with renal insufficiency undergoing hemodialysis
Public title
Evaluation of the effect of Heparin alone and in combination with Vancomycin and Amikabisen in the prevention of tunnel catheter infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Insertion of a new central tunnel catheter for hemodialysis
Absence of inflammation in the vascular access area at the beginning of the study
At least 2 months after starting dialysis
Perform 2 or 3 dialysis sessions per week
Being over 18 years old
No specific diseases such as Leukemia, Infection, Immunodeficiency, Dermatitis
Exclusion criteria:
Having an infectious disease in other parts of the body
Antibiotic use in the previous two weeks
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Blood samples from arterial and venous lines of catheter and peripheral blood for each person
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table is used for randomization. In order to use random numbers table, it will be determined first to read the numbers in the table, then the numbers are considered for different groups. We put our hands on one of the numbers and move in one of the predetermined directions and assign the numbers to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be blinded bilaterally. Patients will be blinded to the type of intervention and the researcher who must enter the data into the relevant checklist will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Fatemi hospital, Imam Khomeini street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۴۷۳۳۷۷۵
Approval date
2021-04-17, 1400/01/28
Ethics committee reference number
IR.ARUMS.REC.1399.632
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Incidence of catheter-related infections in patients under hemodialysis
Timepoint
Six-month follow-up of the two groups
Method of measurement
Blood culture to evaluate for catheter-related infection
Secondary outcomes
1
Description
Fever
Timepoint
During the 6-month follow-up period
Method of measurement
fever measurement
Intervention groups
1
Description
Intervention group A: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group A after obtaining consent. In this group, at the beginning of each dialysis session, 5000 units of heparin (manufactured by Caspin Pharmaceuticals) are injected into each lumen of the catheter, and the patients are evaluated for the occurrence of infection for six months.
Category
Treatment - Drugs
2
Description
Intervention group B: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group B after obtaining consent. In this group, at the beginning of each dialysis session, 5 mg of vancomycin (manufactured by Dana Pharmaceuticals) and 5 mg of amikacin (manufactured by Caspin Pharmaceuticals) plus 5000 units of heparin are injected into each catheter lumen, and the patients are evaluated for the occurrence of infection for six months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Maryam Iranikia
Street address
Fatemi hospital, Imam Khomeini street
City
Ardabil
Province
Ardabil
Postal code
5615741715
Phone
+98 45 3373 2886
Email
Dr.maryam.1983@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammadreza Aslani
Street address
Ardabil University of medical sciences, Daneshghah ave
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 4773
Email
Dr_maryam1983@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Iranikia
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 26, Molavi st, Shahid hamzezadeh st, Hafez ave
City
Ardabil
Province
Ardabil
Postal code
5615741715
Phone
+98 45 3373 2886
Email
Dr.maryam.1983@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Iranikia
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 26, Molavi st, Shahid hamzezadeh st, Hafez ave
City
Ardabil
Province
Ardabil
Postal code
5615741715
Phone
+98 45 3373 2886
Email
Dr.maryam.1983@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Iranikia
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 26, Molavi st, Shahid hamzezadeh st, Hafez ave
City
Ardabil
Province
Ardabil
Postal code
5615741715
Phone
+98 45 3373 2886
Email
Dr.maryam.1983@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Individual data from study participants included demographic information, medical history, and evidence of catheter-related infection
When the data will become available and for how long
Access starts six months after the results are published
To whom data/document is available
Researchers working in academic and medical centers , physicians and medical students
Under which criteria data/document could be used
For reference in conducting similar studies by mentioning the original source
From where data/document is obtainable
Ardabil University of Medical Sciences, Vice Chancellor for Research or email Dr_maryam1983@gmail.com
What processes are involved for a request to access data/document
Contact by email or refer to the Vice Chancellor for Research of Ardabil University of Medical Sciences and make a request, full explanation of the purpose of having the data, provide a guarantee to mention the source