Catheter-Related Infections, Citrate Adverse Reaction
Conditions
Keywords
Catheter Lock, Trisodium Citrate
Brief 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.
Interventions
DEVICELocking 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.
Sponsors
Syneos Health
Veeva Systems
Medical Components, Inc dba MedComp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant females will be eligible for study entry provided that all inclusion/
Exclusion criteria
are satisfied. Patients must fulfill all of the following inclusion criteria to be eligible for participation in the study: 1. Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period. 2. Patients undergoing HD 3 or 4 times per week in clinic (expected to continue for the length of the study) with an established or newly placed non-tunneled or tunneled HD CVC as primary vascular access. 3. Adult male or female patients, aged ≥18 years at the time of screening. 4. Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing. 5. Expected to survive for the next 6 months and the patient is likely to require the use of a CVC for at least 90 days. 6. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Catheter Patency | 90 days | Catheter Flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRBSI | 90 Days | Incidence of catheter-related bloodstream infection (CRBSI) over the course of the study |
Countries
France
Outcome results
None listed