NCT06660641

Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections

TaurolockTMHep100 Versus Saline 0.9% As Secondary Prevention of Catheter-related Bloodstream Infections (CRBSI); a Single Center, Double Blinded, Randomized, Controlled Study in Patients with Chronic Intestinal Failure Dependent on Home Parenteral Support (HPS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.

Detailed description

Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. 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, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs. Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme. Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence. Duration of the instillation will be 24 months.

Conditions

• Catheter Related Blood Stream Infections
• Intestinal Failure

Interventions

Type	Name	Description
DEVICE	TaurolockTMHep100	1.35% taurolidine containing catheter losk solution
DEVICE	0.9 % saline	placebo

Timeline

• Start date: 2019-06-03
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: Denmark