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

Rigshospitalet logo

Rigshospitalet

Status

Completed

Conditions

Intestinal Failure
Catheter Related Blood Stream Infections

Treatments

Device: 0.9 % saline
Device: TaurolockTMHep100

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06660641
H-19000051

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:

  1. Signed informed consent form
  2. Has a single-lumen subcutaneously tunneled CVC
  3. Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI

Exclusion criteria

Patients who:

  1. have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
  2. are pregnant, lactating or nursing

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

61 participants in 2 patient groups, including a placebo group

TaurolockTMHep100
Active Comparator group
Treatment:
Device: TaurolockTMHep100
0.9% saline
Placebo Comparator group
Treatment:
Device: 0.9 % saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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