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NCT00749619 Clinical Trial

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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00749619
Other study ID # TAURO 070908
Secondary ID
Status Completed
Phase Phase 3
First received September 7, 2008
Last updated September 8, 2008
Start date May 2007
Est. completion date August 2008

Study information
Verified date September 2008
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Hemodialysis patients with new TCC

- Informed Consent

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Catheter Lock Solution Taurolidine and Citrate

• Catheter Lock Solution :Taurolidine and Citrate and Heparin

• Catheter Lock Solution : Heparin

Locations
Country Name City State
Israel Western Galilee Hospital Nahariya

Sponsors (1)
Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

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