Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%

Geert Wanten

Status: Completed

Conditions: Catheter Related Blood Stream Infections

Treatments: Device: TauroSept®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01826526

TCL-0112

Details and patient eligibility

About

The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.

Full description

Home Parenteral Nutrition has become a mainstay in the support of patients with chronic intestinal failure. It requires the presence of a central venous catheter to assure adequate venous access. Catheter Related BloodStream Infections (CRBSIs) are frequent. Most CRBSIs originate from contamination of the catheter hub and subsequent growth of microorganisms embedded within the biofilm that rapidly develops on the inner catheter surface. The best preventive measure against the development of CRBSIs is observation of strict hygiene guidelines when inserting and manipulating a central venous catheter and in addition to this the instillation of antimicrobial solutions like TauroSept® or saline solution 0.9% into the catheter lumen (antimicrobial lock). This measure is currently widely used in clinical practice.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Benign underlying disease leading to long-term intestinal failure who will receive HPN and/or fluids (saline and/or glucose) at least 2 times /week over a subcutaneously tunnelled single-lumen Central Venous Catheter (CVC) (Hickman/Broviac or subcutaneous port) for at least one year

  1. Patient receives a new single lumen central vascular access device for HPN (new patient starting HPN or patient already on HPN) allocation to Group I = new catheter group] or
  2. Patient is already on HPN for ≥1 year prior to trial inclusion and has a CRBSI rate (bacterial and/or yeast infections) of >0.3/year and a catheter that has been in place for ≥6 months (allocation to Group II = high risk group). (Previous salvage of this catheter by line-lock antibiotics or other therapeutic interventions is not an exclusion criterion as long as this has been performed at least two months before enrolment in the trial)

• Estimated life expectancy ≥1 year

• Male or female patient aged 18 - 80 years

• Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

Exclusion criteria

• cannot be expected to comply with the trial plan (substance abuse, mental condition)
• has significant cardiovascular disease such as unstable angina, acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
• has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0.9% and/or their excipients.
• is pregnant, lactating, or nursing.
• has a current bloodstream infection
• has any clinically significant abnormalities in blood coagulation requiring intervention
• has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
• has received an investigational drug within 30 days of trial entry
• has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
• has received a Taurolidine lock previously
• has compromised skin integrity, including any infection at the insertion site
• has received parenteral or oral antibiotic therapy <2months prior trial inclusion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

TauroSept®

Active Comparator group

Description:

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of TauroSept® administration in this trial will be 12 months.

Treatment:

Device: TauroSept®

Saline solution 0.9%

Placebo Comparator group

Description:

5 ml of saline will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of saline administration in this trial will be 12 months.

Treatment:

Device: TauroSept®