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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749619
First Posted: September 9, 2008
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Western Galilee Hospital-Nahariya
  Purpose
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.

Condition Intervention Phase
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 Type: Interventional
Study Design: Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis patients with new TCC
  • Informed Consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749619


Locations
Israel
Western Galilee Hospital
Nahariya, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

ClinicalTrials.gov Identifier: NCT00749619     History of Changes
Other Study ID Numbers: TAURO 070908
First Submitted: September 7, 2008
First Posted: September 9, 2008
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Western Galilee Hospital-Nahariya:
Tunneled Cuffed Catheter
Catheter Lock Solution
Catheter Related Bacteremia

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Calcium heparin
Heparin
Citric Acid
Taurolidine
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents