A Phase 4 interventional study of TaurolockTMHep100 and Heparin 100 IE/ml in Catheter-related Bloodstream Infection (CRBSI) Nos, sponsored by Palle Bekker Jeppesen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Palle Bekker Jeppesen · Phase 4, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 42 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Palle Bekker Jeppesen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who:
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).
Device: TaurolockTMHep100
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).
Device: Heparin 100 IE/ml
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.
Also known as: Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml
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.
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
Patient satisfaction with the assigned catheter lock solution in each group
1= not at all satisfied, 2= unsatisfied, 3= satisfied, 4= very satisfied
Time frame: 24 months
Costs of catheter lock solution plus cost of hospitalization, unscheduled outpatient-clinic consultations, drug treatment costs of infections and catheter changes
Time frame: 24 months
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.