Back to resultsAddition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
Primary Purpose
End Stage Renal Disease, Hemodialysis
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Catheter Lock Solution Taurolidine and Citrate
Catheter Lock Solution :Taurolidine and Citrate and Heparin
Catheter Lock Solution : Heparin
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring Tunneled Cuffed Catheter, Catheter Lock Solution, Catheter Related Bacteremia
Eligibility Criteria
Inclusion Criteria:
- Hemodialysis patients with new TCC
- Informed Consent
Sites / Locations
- Western Galilee Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00749619
First Posted
September 7, 2008
Last Updated
September 8, 2008
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT00749619
Brief Title
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.
Detailed Description
Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction.
The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine &citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.
Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.
The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis
Keywords
Tunneled Cuffed Catheter, Catheter Lock Solution, Catheter Related Bacteremia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Catheter Lock Solution Taurolidine and Citrate
Intervention Type
Other
Intervention Name(s)
Catheter Lock Solution :Taurolidine and Citrate and Heparin
Intervention Type
Other
Intervention Name(s)
Catheter Lock Solution : Heparin
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemodialysis patients with new TCC
Informed Consent
Facility Information:
Facility Name
Western Galilee Hospital
City
Nahariya
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
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