Clinical Trials Directory

Trials / Completed

CompletedNCT00749619

Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
Sponsor
Western Galilee Hospital-Nahariya · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCatheter Lock Solution Taurolidine and Citrate
OTHERCatheter Lock Solution :Taurolidine and Citrate and Heparin
OTHERCatheter Lock Solution : Heparin

Timeline

Start date
2007-05-01
Primary completion
2008-08-01
Completion
2008-08-01
First posted
2008-09-09
Last updated
2008-09-09

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00749619. Inclusion in this directory is not an endorsement.