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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
42
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.
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.
Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
Copenhagen, Denmark
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Time frame: 24 months
Median time to a catheter related blood stream infection(CRBSI) in each group.
Time frame: 24 months
Number and frequency of catheter removals due to catheter-related infections in each group
Time frame: 24 months
Number and frequency of exit site infections in each group
Time frame: 24 months
Median time to catheter removal due to catheter-related infections in each group
Time frame: 24 months
Number and frequency of catheter occlusions in each group
Time frame: 24 months
Number and frequency of patients having serious adverse event and adverse event in each group
Time frame: 24 months
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