Taurolidine Lock in Long Term Parenteral Nutrition

December 10, 2013 updated by: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

The Value of Taurolidine Lock in Long Term Parenteral Nutrition

Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Skawina, Poland, 32-050
        • Stanley Dudrick's Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • home parenteral nutrition for at least months before enrollment
  • presence of central venous cathter

Exclusion Criteria:

  • home nutrition < 12 months
  • catheter in peripheral vein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Saline flush
Catheter lock with 2% Taurolidine
Catheter lock with 1.35% Taurolidine + citrate
ACTIVE_COMPARATOR: 2% Taurolidine lock
Catheter lock with 2% Taurolidine
Catheter lock with 2% Taurolidine
Catheter lock with 1.35% Taurolidine + citrate
ACTIVE_COMPARATOR: 1.35% Taurolidine with citrate
Catheter lock with 1.35% Taurolidine + citrate
Catheter lock with 2% Taurolidine
Catheter lock with 1.35% Taurolidine + citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CVC infections
Time Frame: 12 months
Number of central venous catheter infections
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stanislaw Klek, Assoc Prof, Stanley Dudrick's Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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