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| ID | Type | Description | Link |
|---|---|---|---|
| 38202 | Other Identifier | The National Committee on Health Research Ethics, Denmark |
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| Name | Class |
|---|---|
| TauroPharm | INDUSTRY |
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The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition.
Patients with long-term intestinal failure are dependent on Home Parenteral Nutrition(HPN) delivered through a central venous access device(CVAD), placed as a subcutaneous tunneled catheter(Broviac). Catheter Related Blood Stream Infections(CRBSI) is a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of their tunneled catheter. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, TaurolockTMHep100 and Heparin 100 IE/ml, on the occurence of CRBSI. The secondary objectives are to compare the two devices according to other efficacy parameters, time to infection, cost and resource utility, tolerability and safety.
Patients with a prior high risk of CRBSI will be included. Patients will instill the solution in their CVAD after each infusion of HPN, varying between minimum twice per week to once daily, depending on their individual HPN programme.
Before the blinded randomization the patients will be paired according to gender, age and prior infection risk.
Duration of the instillation will be 24 month or until outcome(CRBSI) accure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TaurolockTMHep100 | Active Comparator | 2-4 ml of TaurolockTMHep100 will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion. The duration of TaurolockTMHep100 administration will be maximum 24 month or until occurence of primary outcome(CRBSI). |
|
| Heparin 100 IE/ml | Placebo Comparator | 2-4 ml of Heparin 100 IE/mk will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion. The duration of Heparin 100 IE/ml administration will be maximum 24 month or until occurence of primary outcome(CRBSI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TaurolockTMHep100 | Device | 2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to a catheter related blood stream infection(CRBSI) in each group. | 24 months | |
| Number and frequency of catheter removals due to catheter-related infections in each group | 24 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with the assigned catheter lock solution in each group | 1= not at all satisfied, 2= unsatisfied, 3= satisfied, 4= very satisfied | 24 months |
| Costs of catheter lock solution plus cost of hospitalization, unscheduled outpatient-clinic consultations, drug treatment costs of infections and catheter changes |
Inclusion Criteria:
Exclusion Criteria:
Patients who:
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| Name | Affiliation | Role |
|---|---|---|
| Palle B Jeppesen, Ass. Prof. | Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121 | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 28793993 | Derived |
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| ID | Term |
|---|---|
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
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|
|
| Heparin 100 IE/ml | Device | 2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids. |
|
| Number and frequency of exit site infections in each group |
| 24 months |
| Median time to catheter removal due to catheter-related infections in each group | 24 months |
| Number and frequency of catheter occlusions in each group | 24 months |
| Number and frequency of patients having serious adverse event and adverse event in each group | 24 months |
| 24 months |
| Tribler S, Brandt CF, Petersen AH, Petersen JH, Fuglsang KA, Staun M, Broebech P, Moser CE, Jeppesen PB. Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial. Am J Clin Nutr. 2017 Sep;106(3):839-848. doi: 10.3945/ajcn.117.158964. Epub 2017 Aug 9. |
| D004066 |
| Digestive System Diseases |