DuraLock-C Catheter Lock Solution

Status Terminated

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Catheter-Related Infections

Clinical Trial Details

NCT number	NCT04787926
Study type	Observational
Source	Medical Components, Inc dba MedComp
Contact
Status	Terminated
Phase
Start date	September 23, 2021
Completion date	June 1, 2023

View Details

See also
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