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

NCT ID: NCT00749619

Last Updated: 2008-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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

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End Stage Renal Disease Hemodialysis

Keywords

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Tunneled Cuffed Catheter Catheter Lock Solution Catheter Related Bacteremia

Study Design

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Primary Study Purpose

PREVENTION

Study Groups

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A

Group Type EXPERIMENTAL

Catheter Lock Solution Taurolidine and Citrate

Intervention Type OTHER

B

Group Type EXPERIMENTAL

Catheter Lock Solution :Taurolidine and Citrate and Heparin

Intervention Type OTHER

C

Group Type NO_INTERVENTION

Catheter Lock Solution : Heparin

Intervention Type OTHER

Interventions

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Catheter Lock Solution Taurolidine and Citrate

Intervention Type OTHER

Catheter Lock Solution :Taurolidine and Citrate and Heparin

Intervention Type OTHER

Catheter Lock Solution : Heparin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hemodialysis patients with new TCC
* Informed Consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Locations

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Western Galilee Hospital

Nahariya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TAURO 070908

Identifier Type: -

Identifier Source: org_study_id