Taurolidine 2% catheter locking to prevent catheter-related bloodstream infections in patients on home parenteral nutrition with a high infection risk and those with a new central venous access device: A double-blind multicenter randomized controlled trial under guidance of the Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPE

Conditions: intestinal failure, home parenteral nutrition
catheter-related bloodstream infections (CRBSI)
10004018

Registration Number: NL-OMON36907

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. 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 (Hickman/Broviac or subcutaneous port) for at least one year ;2. a) 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
b) 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)
3. Estimated life expectancy >=1 year
4. Male or female patient aged 18 - 80 years
5. Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

Exclusion Criteria

Patient who:
1. cannot be expected to comply with the trial plan (substance abuse, mental condition)
2. 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
3. has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0.9%
4. is pregnant, lactating, or nursing.
5. has a current bloodstream infection
6. has any clinically significant abnormalities in PT or PTT requiring intervention
7. has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
8. has received an investigational drug within 30 days of trial entry
9. has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
10. has compromised skin integrity, including any infection at the insertion site
11. has received parenteral or oral antibiotic therapy < 2 months prior trial inclusion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br><br /><br>Mean number of CRBSI/1*000 catheter days<br /><br><br /><br>(Note: Patients without infection after 1 year will have a value of 0.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br><br /><br>1. Median time to CRBSI<br /><br>2. Number and frequency of catheter removals due to catheter-related infections<br /><br>3. Median time to catheter removal due to catheter-related infections<br /><br>4. Number and frequency of exit site infections<br /><br>5. Number and frequency of catheter occlusions<br /><br>6. Patient satisfaction with the assigned catheter lock solution<br /><br>7. Costs of catheter lock solution plus costs of hospitalizations, unscheduled<br /><br>outpatient-clinic consultations, drug treatment costs of infections and<br /><br>catheter changes<br /><br>8. Number and frequency of patients having serious adverse events and adverse<br /><br>events </p><br>