Status:
COMPLETED
Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
Lead Sponsor:
Geert Wanten
Collaborating Sponsors:
Geistlich Pharma AG
Conditions:
Catheter Related Blood Stream Infections
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed 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. Cath...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01826526
Start Date
June 1 2013
End Date
November 1 2016
Last Update
December 6 2016
Active Locations (7)
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1
University Hospital Copenhagen Rigshospitalet
Copenhagen, Denmark, 2100
2
University Clinic Münster
Münster, Germany, 48149
3
Rabin Medical Center
Petah Tikva, Israel, 49100
4
University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
Bologna, Italy, 40138