Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
|End Stage Renal Disease Hemodialysis||Other: Catheter Lock Solution Taurolidine and Citrate Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin Other: Catheter Lock Solution : Heparin||Phase 3|
|Study Design:||Primary Purpose: Prevention|
|Study Start Date:||May 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Experimental: A||Other: Catheter Lock Solution Taurolidine and Citrate|
|Experimental: B||Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin|
|No Intervention: C||Other: Catheter Lock Solution : Heparin|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749619
|Western Galilee Hospital|