NCT04787926

DuraLock-C Catheter Lock Solution

A Multicenter, Open-Label Study to Evaluate the Safety and Performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the Maintenance of Central Venous Catheter Patency in Adult Hemodialysis Subjects Treated in Clinic

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Medical Components, Inc dba MedComp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the maintenance of central venous catheter (CVC) patency in adult hemodialysis (HD) patients

Detailed description

This study is a multicenter, open-label, post-market study to evaluate the safety and performance of DuraLock-C 4.0%, 30.0%, and 46.7% in the maintenance of catheter patency of an indwelling HD CVC in adult HD patients treated in clinic. On Day 0, patients to be instilled who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study to receive 1 of the 3 DuraLock-C solutions. It is expected that a minimum of 3 sites will enroll patients to the study in order to cover the 3 solutions to be tested; each site will enroll to 1 unique DuraLock-C solution only, until the sample size for the solution has been reached. DuraLock-C 4.0%, 30.0%, or 46.7% solutions will be instilled to lock the catheter as part of the routine care of the patient. Individual patients will receive the catheter locking solution (CLS) as a catheter lock post-HD session until catheter dysfunction is observed or until the end of the study period (Calendar Day 90). The CLSs are commercially available and will not be provided as part of the study design. End of Study (EOS) will take place at the patient's next scheduled session.

Conditions

• Catheter-Related Infections
• Citrate Adverse Reaction

Interventions

Type	Name	Description
DEVICE	Locking Solution	The total duration of the study treatment period will be 90 calendar days, from Visit 1 Pre-Instillation to the last study-related assessment. Two to 3 instillations (1 per lumen per visit) of DuraLock-C 4.0%, 30.0%, or 46.7% (equivalent to the catheter manufacturer's prescribed priming volume) will be instilled 1 to 3 days apart (with a HD schedule of 3 to 4 times per week); each instillation of CLS will remain in the CVC for approximately 24 to 72 hours ± 12 hours, based on their practice preferences. EOS will take place at the patient's next scheduled dialysis session.

Timeline

• Start date: 2021-09-23
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-03-09
• Last updated: 2024-01-10

Locations

1 site across 1 country: France