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NCT02009189 Clinical Trial

Taurolidine Lock in Long Term Parenteral Nutrition

Central Venous Catheter Clinical Trial

Official title:
The Value of Taurolidine Lock in Long Term Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02009189
Other study ID # Tauro-1
Secondary ID
Status Completed
Phase Phase 4
First received December 8, 2013
Last updated December 10, 2013
Start date November 2012
Est. completion date December 2013

Study information
Verified date December 2013
Source Stanley Dudrick's Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• 2% Taurolidine Lock
Catheter lock with 2% Taurolidine
• 1.35% Taurolidine
Catheter lock with 1.35% Taurolidine + citrate

Locations
Country Name City State
Poland Stanley Dudrick's Memorial Hospital Skawina

Sponsors (1)
Lead Sponsor Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of CVC infections Number of central venous catheter infections 12 months No
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