To compare the efficacy of TaurolockHEP500®, as half and one third of standard dose on prevention of catheter related blood stream infection and catheter dysfunction in patients undergoing hemodialysis via tunneled double lumen catheter.
Design
Two arm parallel group randomized trial, phase N/A, sample size of 314 , two centers
Settings and conduct
Randomized controlled study was conducted at Armed Forces Institute of Urology Rawalpindi and Pak Emirates Military Hospital Rawalpindi from September, 2023 to April, 2024.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: This study included patients who were undergoing hemodialysis via a tunneled double lumen catheter with blood flow rate (BFR) of > 250 mL/min at the start of the study and without previous history of CRBSI.
Exclusion Criteria: Patients with catheter dysfunction defined by a (BFR) of < 250 mL/min, allergic to used drugs, with previous history of catheter dysfunction and CRBSI, IV drug abusers, changing dialysis from catheter to AVF were excluded from the study.
Intervention groups
After every hemodialysis session, an injection TaurolockHEP500® was administered into the tunnelled double-lumen catheter in half dose for Group A (Intervention Group 1) and one-third dose for Group B (Intervention Group 2). The rest of the space in the catheter’s lumen was filled with heparin. All the patients were then followed for three months.
Main outcome variables
Fever and rigors during hemodialysis
CRP
Blood flow rate during hemodialysis
Blood culture and sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240921063106N1
Registration date:2024-10-01, 1403/07/10
Registration timing:retrospective
Last update:2024-10-01, 1403/07/10
Update count:0
Registration date
2024-10-01, 1403/07/10
Registrant information
Name
Ghulam Mustafa
Name of organization / entity
Armed Forces Institute of Urology Rawalpindi pakistan
Country
Pakistan
Phone
+92 312 5803252
Email address
ghulammustafa842@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-15, 1402/06/24
Expected recruitment end date
2023-12-15, 1402/09/24
Actual recruitment start date
2023-09-15, 1402/06/24
Actual recruitment end date
2024-01-30, 1402/11/10
Trial completion date
2024-04-30, 1403/02/11
Scientific title
Efficacy of Half Dose and One Third Dose of Injection Taurolock® for Tunneled Double Lumen Catheter Lock Solution
Public title
Dialysis catheter lock solution
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who were undergoing hemodialysis via a tunneled double lumen catheter with blood flow rate (BFR) of > 250 mL/min at the start of the study
No previous history of catheter related blood stream infection
Exclusion criteria:
Patients allergic to used drugs(TaurolockHEP500®)
IV drug abusers
Changing dialysis from catheter to AVF
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
314
Actual sample size reached:
314
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using computer-generated sequences, prepared online.
End Stage Kidney Disease patient undergoing Hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Blood flow rate
Timepoint
Blood flow rate during each session of hemodialysis
Method of measurement
Blood flow rate checked during hemodialysis from blood pump of dialysis machine.
2
Description
Blood culture for identifying infection
Timepoint
The blood sample will be collected if patients develops fever or shivering during or within 4 hours after hemodialysis session.
Method of measurement
The blood will be drawn from venous circulation by using strile blood sample collecting syringes. The collected sample will be transferred to and preserved in blood sample bottles.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group will receive a half dose of injection taurolockHEP500® into the lumens of the tunnelled catheter after each dialysis session for three months.
Category
Treatment - Drugs
2
Description
Intervention group 2:This group will receive a one-third dose of injection taurolockHEP500® into the lumens of the tunnelled catheter after each dialysis session for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Armed Forces Institute Of Urology Rawalpindi
Full name of responsible person
Ghulam Mustafa
Street address
CMH road Rawalpindi Punjab
City
Rawalpindi
Postal code
46000
Phone
+92 340 8913290
Email
ghulammustafa842@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed Forces Institute Of Urology Rawalpindi
Full name of responsible person
Ghulam Mustafa
Street address
CMH road Rawalpindi Punjab
City
Rawalpindi
Postal code
46000
Phone
+92 340 8913290
Email
ghulammustafa842@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed Forces Institute Of Urology Rawalpindi
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
Armed Forces Institute Of Urology Rawalpindi
Full name of responsible person
Ghulam Mustafa
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Nephrology
Street address
CMH road Rawalpindi Punjab
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 340 8913290
Email
ghulammustafa842@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Institute Of Urology Rawalpindi
Full name of responsible person
Ghulam Mustafa
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Nephrology
Street address
CMH road Rawalpindi Punjab
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 340 8913290
Email
ghulammustafa842@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Institute Of Urology Rawalpindi
Full name of responsible person
Ghulam Mustafa
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Nephrology
Street address
CMH road Rawalpindi Punjab
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 340 8913290
Email
ghulammustafa842@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