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)

A prospective, randomized, multicenter trial to compare a Taurolock™ based lock solution to a Citrate and Citrate/Urokinase based lock solution in tunneled hemodialysis catheters for the prevention of bacteremia and dysfunction - CathLock Trial Dialysis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001340-22-AT

Enrollment

240

Registered

2020-01-14

Start date

2020-02-24

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Actosolv Product Name: Actosolv Product Code: Actosolv Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Actosolv CAS Number: 9039-53-6 Current Sponsor code: Uroki

Eligibility

Sex/Gender

All

Inclusion 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

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim of this study is to evaluate a CLS regime of Citrate, a CLS regime of citrate combined with Urokinase and a Taurolodine-based CLS regarding catheter-related bloodstream infections and catheter dysfunctions Protocol_Locksolutions_Dialysis Page 7/26 Version 1.1. Primary outcome variable: § Total number of CRBSI;Secondary Objective: § Total number of catheter dysfunctions § Rate of catheter removal or exchange due to dysfunctions § Rate of necessity of catheter rescue with Alteplase § Rate of infections per 1000 catheter days § Rate of catheter exchange due to infections § Survival without any CRBSI § Hospitalization (number and days of hospitalization) § Cost analysis (incl. medication, hospitalization) § Use of antibiotics (number of episodes and days);Primary end point(s): Primary outcome variables: § Total number of CRBSI;Timepoint(s) of evaluation of this end point: until occurence of first CRBSI, maximum of 24 months,	—

Measure

Time frame

Main Objective: Aim of this study is to evaluate a CLS regime of Citrate, a CLS regime of citrate combined with Urokinase and a Taurolodine-based CLS regarding catheter-related bloodstream infections and catheter dysfunctions Protocol_Locksolutions_Dialysis Page 7/26 Version 1.1. Primary outcome variable: § Total number of CRBSI;Secondary Objective: § Total number of catheter dysfunctions § Rate of catheter removal or exchange due to dysfunctions § Rate of necessity of catheter rescue with Alteplase § Rate of infections per 1000 catheter days § Rate of catheter exchange due to infections § Survival without any CRBSI § Hospitalization (number and days of hospitalization) § Cost analysis (incl. medication, hospitalization) § Use of antibiotics (number of episodes and days);Primary end point(s): Primary outcome variables: § Total number of CRBSI;Timepoint(s) of evaluation of this end point: until occurence of first CRBSI, maximum of 24 months,

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome variables: § Total number of catheter dysfunctions § Rate of catheter removal or exchange due to dysfunctions § Rate of necessity of catheter rescue with Alteplase § Rate of infections per 1000 catheter days § Rate of catheter exchange due to infections § Survival without any CRBSI § Hospitalization (number and days of hospitalization) § Cost analysis (incl. medication, hospitalization) § 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	—

Measure

Time frame

Secondary end point(s): Secondary outcome variables: § Total number of catheter dysfunctions § Rate of catheter removal or exchange due to dysfunctions § Rate of necessity of catheter rescue with Alteplase § Rate of infections per 1000 catheter days § Rate of catheter exchange due to infections § Survival without any CRBSI § Hospitalization (number and days of hospitalization) § Cost analysis (incl. medication, hospitalization) § 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

—

Countries

Austria

Contacts

Public ContactDepartment of Internal Medicine 1

Universitätsklinikum St.Pölten

interne1@stpoelten.lknoe.at+432742900412141

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026