- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009189
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tauro-1
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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