Taurolidine 2% catheter locking to prevent catheter-related bloodstream infections in patients on home parenteral nutrition with a high infection risk and those with a new central venous access device: A double-blind multicenter randomized controlled trial under guidance of the Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN - Research with catheter lock TauroSept® (taurolidine 2%) or saline 0,9%

niversitair Medisch Centrum Sint Radboud0 sites20 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

niversitair Medisch Centrum Sint Radboud

•1\. Benign underlying disease leading to long\-term intestinal failure who will receive HPN and/or fluids (saline and/or glucose) at least 2 times /week over a subcutaneously tunnelled single\-lumen central venous catheter (Hickman/Broviac or subcutaneous port) for at least one year ;2\. a) Patient receives a new single lumen central vascular access device for HPN (new patient starting HPN or patient already on HPN) \[allocation to Group I \= new catheter group]
•b) Patient is already on HPN for \>\=1 year prior to trial inclusion and has a CRBSI rate (bacterial and/or yeast infections) of \>0\.3/year and a catheter that has been in place for \>\=6 months (allocation to Group II \= high risk group).
•(Previous salvage of this catheter by line\-lock antibiotics or other therapeutic interventions is not an exclusion criterion as long as this has been performed at least two months before enrolment in the trial)
•3\. Estimated life expectancy \>\=1 year
•4\. Male or female patient aged 18 \- 80 years
•5\. Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

•Patient who:
•1\. cannot be expected to comply with the trial plan (substance abuse, mental condition)
•2\. has significant cardiovascular disease such as unstable angina, acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
•3\. has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0\.9%
•4\. is pregnant, lactating, or nursing.
•5\. has a current bloodstream infection
•6\. has any clinically significant abnormalities in PT or PTT requiring intervention
•7\. has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80\-325 mg daily is acceptable).
•8\. has received an investigational drug within 30 days of trial entry
•9\. has an antibiotic coated, silver impregnated or antimicrobial cuff catheter