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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western Galilee Hospital

Nahariya, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hemodialysis patients with new TCC
Informed Consent

Treatment and study plan

Catheter Lock Solution Taurolidine and Citrate

Other

Catheter Lock Solution :Taurolidine and Citrate and Heparin

Other

Catheter Lock Solution : Heparin

Other

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 9, 2008
Registry last updated: Sep 9, 2008

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed