A comparison of different lock Solutions (i.e. medicine that prevents dysfunktion of central venuos catheter in hemodialysis patients) regarding catheter related infections (i.e. blood poisioning due to bacteria)
- Conditions
- Patients requiring hemodialysis with a CVC due to renal failure of any cause. Aim of this study is to investigate different CVC lock Solutions.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-001340-22-AT
- Lead Sponsor
- niverstitätsklinikum St.Pölten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 240
§ Male or female older than 18 years
§ Requirement for hemodialysis using a tunneled dialysis catheter
§ Willingness and ability to comply with the protocol
§ Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
§ Children aged less than 18 years
§ Any systemic infection prior 7 days before catheter insertion
§ Positive blood culture in previous 7 days before catheter
insertion
§ Heparin induced thrombocytopenia and/or contraindication for
anticoagulation (recent or planned surgery, thrombocytopenia <
70G/l, bleeding disorder)
§ Allergy or hypersensitivity against study drug or devices
§ Any disease considered relevant for proper performance of the
study or risks to the patient, at the discretion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Aim of this study is to evaluate a CLS regime of Citrate, a CLS<br>regime of citrate combined with Urokinase and a Taurolodine-based CLS <br>regarding catheter-related bloodstream infections and catheter dysfunctions<br>Protocol_Locksolutions_Dialysis Page 7/26 Version 1.1.<br><br><br>Primary outcome variable:<br>§ Total number of CRBSI;Secondary Objective: § Total number of catheter dysfunctions<br>§ Rate of catheter removal or exchange due to dysfunctions<br>§ Rate of necessity of catheter rescue with Alteplase<br>§ Rate of infections per 1000 catheter days<br>§ Rate of catheter exchange due to infections<br>§ Survival without any CRBSI<br>§ Hospitalization (number and days of hospitalization)<br>§ Cost analysis (incl. medication, hospitalization)<br>§ Use of antibiotics (number of episodes and days);Primary end point(s): Primary outcome variables:<br>§ Total number of CRBSI;Timepoint(s) of evaluation of this end point: until occurence of first CRBSI, maximum of 24 months,
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary outcome variables:<br>§ Total number of catheter dysfunctions<br>§ Rate of catheter removal or exchange due to dysfunctions<br>§ Rate of necessity of catheter rescue with Alteplase<br>§ Rate of infections per 1000 catheter days<br>§ Rate of catheter exchange due to infections<br>§ Survival without any CRBSI<br>§ Hospitalization (number and days of hospitalization)<br>§ Cost analysis (incl. medication, hospitalization)<br>§ Use of antibiotics (number of episodes and days);Timepoint(s) of evaluation of this end point: All endpoints will be documented during the observation period, which is until first occurrence of CRBSI or a maximum of 24 months