Clinical trial NCT01826526: Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Blood Stream Infections
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2013-04-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 (CVC) (Hickman/Broviac or subcutaneous port) for at least one year

  1. 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\] or
  2. 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)
* Estimated life expectancy ≥1 year
* Male or female patient aged 18 - 80 years
* Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

Exclusion Criteria:

* cannot be expected to comply with the trial plan (substance abuse, mental condition)
* 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
* has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0.9% and/or their excipients.
* is pregnant, lactating, or nursing.
* has a current bloodstream infection
* has any clinically significant abnormalities in blood coagulation requiring intervention
* has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
* has received an investigational drug within 30 days of trial entry
* has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
* has received a Taurolidine lock previously
* has compromised skin integrity, including any infection at the insertion site
* has received parenteral or oral antibiotic therapy \<2months prior trial inclusion

Primary outcomes:
measure: Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group
timeFrame: 12 months
Secondary outcomes:
measure: Median time to a catheter related blood stream infection CRBSI per patient per group
timeFrame: 12 months
Other outcomes:
Locations:
city: København
country: Denmark
facility: University Hospital Copenhagen Rigshospitalet
city: Münster
country: Germany
facility: University Clinic Münster
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Bologna
country: Italy
facility: University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
city: Nijmegen
country: Netherlands
facility: Department of Gastroenterology and Hepatology clinical ward
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: Middlesex
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
References:
citation: Bisseling TM, Willems MC, Versleijen MW, Hendriks JC, Vissers RK, Wanten GJ. Taurolidine lock is highly effective in preventing catheter-related bloodstream infections in patients on home parenteral nutrition: a heparin-controlled prospective trial. Clin Nutr. 2010 Aug;29(4):464-8. doi: 10.1016/j.clnu.2009.12.005. Epub 2010 Jan 12.
citation: Wouters Y, Theilla M, Singer P, Tribler S, Jeppesen PB, Pironi L, Vinter-Jensen L, Rasmussen HH, Rahman F, Wanten GJA. Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition. Aliment Pharmacol Ther. 2018 Aug;48(4):410-422. doi: 10.1111/apt.14904. Epub 2018 Jul 5.
citation: Tribler S, Brandt CF, Fuglsang KA, Staun M, Broebech P, Moser CE, Scheike T, Jeppesen PB. Catheter-related bloodstream infections in patients with intestinal failure receiving home parenteral support: risks related to a catheter-salvage strategy. Am J Clin Nutr. 2018 May 1;107(5):743-753. doi: 10.1093/ajcn/nqy010.