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

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00749619
First received: September 7, 2008
Last updated: September 8, 2008
Last verified: September 2008
  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

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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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis patients with new TCC
  • Informed Consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749619

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

No publications provided

ClinicalTrials.gov Identifier: NCT00749619     History of Changes
Other Study ID Numbers: TAURO 070908
Study First Received: September 7, 2008
Last Updated: September 8, 2008
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Calcium heparin
Citric Acid
Heparin
Taurolidine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014