The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.
Home Parenteral Nutrition has become a mainstay in the support of patients with chronic intestinal failure. It requires the presence of a central venous catheter to assure adequate venous access. Catheter Related BloodStream Infections (CRBSIs) are frequent. Most CRBSIs originate from contamination of the catheter hub and subsequent growth of microorganisms embedded within the biofilm that rapidly develops on the inner catheter surface. The best preventive measure against the development of CRBSIs is observation of strict hygiene guidelines when inserting and manipulating a central venous catheter and in addition to this the instillation of antimicrobial solutions like TauroSept® or saline solution 0.9% into the catheter lumen (antimicrobial lock). This measure is currently widely used in clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
105
5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of TauroSept® administration in this trial will be 12 months.
University Hospital Copenhagen Rigshospitalet
Copenhagen, Denmark
University Clinic Münster
Münster, Germany
Rabin Medical Center
Petah Tikva, Israel
University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
Bologna, Italy
Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group
Time frame: 12 months
Median time to a catheter related blood stream infection CRBSI per patient per group
Time frame: 12 months
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Department of Gastroenterology and Hepatology clinical ward
Nijmegen, Netherlands
St Mark's Hospital
Harrow, Middlesex, United Kingdom
University College Hospital
London, United Kingdom