DuraLock-C Catheter Lock Solution

NCT04787926 | Terminated DMC

• 1 other identifier: 003
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Catheter-Related Infections; Citrate Adverse Reaction

Keywords

Catheter Lock; Trisodium Citrate

Outcome Measures

Primary Outcomes (1)

• Primary Catheter Patency

  Catheter Flow

  90 days

Secondary Outcomes (1)

• CRBSI

  90 Days

Study Arms (3)

Duralock-C 4%

DuraLock-C 4.0%: Pouch Contains: (2) 3 mL Syringes w/ 2.5 mL Trisodium Citrate Dihydrate 40 mg/mL Solution Contains: Trisodium Citrate Dihydrate, Citric Acid Anhydrous, Water

Device: Locking Solution

Duralock-C 30%

DuraLock-C 30.0%: Pouch Contains: (2) 3 mL Syringes w/ 2.5 mL Trisodium Citrate Dihydrate 300 mg/mL Solution Contains: Trisodium Citrate Dihydrate, Citric Acid Anhydrous, Water

Device: Locking Solution

Duralock-C 46.7%

DuraLock-C 46.7%: Pouch Contains: (2) 3 mL Syringes w/ 2.5 mL Trisodium Citrate Dihydrate 467 mg/mL Solution Contains: Trisodium Citrate Dihydrate, Citric Acid Anhydrous, Water

Device: Locking Solution

Interventions

Locking Solution DEVICE

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.

Duralock-C 30%; Duralock-C 4%; Duralock-C 46.7%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing hemodialysis (HD) via a central venous cathter (CVC).

You may not qualify if:

• 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.
• 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.
• Adult male or female patients, aged ≥18 years at the time of screening.
• 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.
• 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.
• Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening
• \. Patients with an arteriovenous fistula or arteriovenous graft in use at the time of the study.
• \. Patients with a history of thromboembolic disease. 3. Patients with a history of HD catheter dysfunction due to thrombosis or a blood pump speed rate \<300 mL/min during HD in the past 30 days.
• \. Patients with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
• \. Patients who received antibiotics within the last 14 days. 6. Have had an acute infection ≤ 30 days prior to enrollment. 7. Known allergy to heparin, including HIT. 8. Patients who received thrombolytic treatment (ie, tissue plasminogen activator \[tPA\]) within 4 weeks of enrollment.
• \. Patients using any type of antimicrobial-coated or heparin-coated catheter. 10. Have a positive serology test for human immunodeficiency virus or hepatitis infection.
• \. Current requirement for systemic immunosuppression that would increase risk of infection or any form of immunosuppressive disease.
• \. Patient is currently taking another medication with known systemic drug interaction with citrate or heparin.
• \. Patient is anticipated to receive a renal transplant within the study period should be excluded.
• \. Patients with known or suspected liver failure. 15. Are female and pregnant, lactating, or planning to become pregnant during the study period.

Sponsors & Collaborators

• Medical Components, Inc dba MedComp: lead
• Syneos Health: collaborator
• Veeva Systems: collaborator

Study Sites (1)

Clinique HEMERA Pays de Caux, 14 .A avenue Foch

Yvetot, France

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: September 23, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

FR (1)