Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
NCT ID: NCT01826526
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2013-06-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TauroSept®
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.
TauroSept®
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.
Saline solution 0.9%
5 ml of saline 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 saline administration in this trial will be 12 months.
TauroSept®
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.
Interventions
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TauroSept®
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Geistlich Pharma AG
INDUSTRY
Geert Wanten
OTHER
Responsible Party
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Geert Wanten
MD, PhD, MSc
Locations
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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
Department of Gastroenterology and Hepatology clinical ward
Nijmegen, , Netherlands
St Mark's Hospital
Harrow, Middlesex, United Kingdom
University College Hospital
London, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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TCL-0112
Identifier Type: -
Identifier Source: org_study_id