The aim of this study is to evaluate the effect of Taurolock and salin5% as lock solutions for prevention of catheter dysfunction and hemodialysis tunneled-catheter related infection.
Design
This is a controlled single-blinded clinical trial study will be conducted on 68 individuals requiring hemodialysis. After coordination and obtaining informed consent, the patients (n=34per group) will be randomly assigned into two groups of salin5% and taurolock and will be follow up for 3 months.
Settings and conduct
From patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter referring to hemodialysis center of Golestan hospital, Ahvaz, Iran total of 68 patients will be selected and randomly divided into 2 groups.In the first group, salin5% will be injected into the lumen of the catheter after each hemodialysis session and catheter locked. In the second group, will be used Taurolock solution as lock antibiotic. The patients will not know about type of treatment and grouping and thus until the end of trial the study will be remained single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter, Consent to participate in the study; Exclusion criteria: using the central venous catheters for anything other than haemodialysis
Intervention groups
In the first group, salin5% will be injected into the lumen of the catheter after each hemodialysis session and catheter locked. In the second group, will be used Taurolock solution as lock antibiotic.
Main outcome variables
Catheter infection and catheter dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042918N1
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Maryam Afkane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 5935
Email address
afkane.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-15, 1397/12/24
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Taurolock and Saline 5% in prevention of hemodialysis catheter infection and dysfunction
Public title
Effect of Taurolock in prevention of catheter infection and dysfunction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter
Age over 18 years
Consent to participate in the study
Exclusion criteria:
Using the central venous catheters for anything other than haemodialysis
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups of experimental and control. Each patient is given a number from 1 to 64 and assignment of patients into the study groups will be done by table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients will not know about grouping and type of intervention (receiving either Taurolock or Saline). Taurolock and saline are placed in the same package (with special code) so that the participants do not understand which group they belong to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Approval date
2018-09-15, 1397/06/24
Ethics committee reference number
IR.AJUMS.REC.1397.412
Health conditions studied
1
Description of health condition studied
Catheter-related infection
ICD-10 code
A49.9
ICD-10 code description
Bacterial infection, unspecified
Primary outcomes
1
Description
Catheter-related infection
Timepoint
After each session hemodialysis for 3 months
Method of measurement
Clinical examination of infection and blood culture
2
Description
Catheter-related dysfunction
Timepoint
In each session of hemodialysis for 3 months
Method of measurement
Blood flow less than 250 cc/min through the CVC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Salin5% will be injected into the lumen of the catheter after each hemodialysis session and catheter locked
Category
Prevention
2
Description
Intervention group: In this group, will be used Taurolock (TauroLock™-Hep 500®) solution as lock antibiotic. Taurolock vial containing taurolidine (antimicrobial agent), 500 units heparin per mL and citrate 4%. lock solution will be injected into the lumen of the catheter after each hemodialysis session and catheter locked
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Ghorbani
Street address
Golestan Hospital, Faevardin Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Ali.ghorbani.001@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8383
Email
badavim@yahoo.com
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
Ali Ghirbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
Ali.ghorbani.001@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghirbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
Ali.ghorbani.001@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghirbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
Ali.ghorbani.001@gmail.com
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