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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TauroSept® | Active Comparator | 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% | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TauroSept® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to a catheter related blood stream infection CRBSI per patient per group | 12 months |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Copenhagen Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| University Clinic Münster |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20061070 | Result | 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. | |
| 29978597 |
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| Münster |
| 48149 |
| Germany |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine | Bologna | 40138 | Italy |
| Department of Gastroenterology and Hepatology clinical ward | Nijmegen | 6500 HB | Netherlands |
| St Mark's Hospital | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| University College Hospital | London | NW1 2PG | United Kingdom |
| 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. |
| 29722835 | Derived | 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. |