EUCTR2019-001340-22-AT
Active, not recruiting
Phase 1
A prospective, randomized, multicenter trial to compare a Taurolock™based lock solution to a Citrate and Citrate/Urokinase based locksolution in tunneled hemodialysis catheters for the prevention ofbacteremia and dysfunction - CathLock Trial Dialysis
niverstitätsklinikum St.Pölten0 sites240 target enrollmentJanuary 14, 2020
ConditionsPatients 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]
DrugsActosolv
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- niverstitätsklinikum St.Pölten
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •§ 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
Exclusion Criteria
- •§ Children aged less than 18 years
- •§ Any systemic infection prior 7 days before catheter insertion
- •§ Positive blood culture in previous 7 days before catheter
- •§ 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
Outcomes
Primary Outcomes
Not specified
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