Catheter-Related InfectionsNCT04787926
DuraLock-C Catheter Lock Solution
An observational study of Catheter-Related Infections and Citrate Adverse Reaction, run by Medical Components, Inc dba MedComp at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Citrate Adverse Reaction
- What is being tested?
- Locking Solution
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing hemodialysis (HD) via a central venous cathter (CVC).
Who may be able to join
- 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:
- 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
Who cannot join
- 1. Patients with an arteriovenous fistula or arteriovenous graft in use at the time of the study.
- 2. 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.
- 4. Patients with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
- 5. 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.
- 9. Patients using any type of antimicrobial-coated or heparin-coated catheter. 10. Have a positive serology test for human immunodeficiency virus or hepatitis infection.
- 11. Current requirement for systemic immunosuppression that would increase risk of infection or any form of immunosuppressive disease.
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- 12. Patient is currently taking another medication with known systemic drug interaction with citrate or heparin.
- 13. Patient is anticipated to receive a renal transplant within the study period should be excluded.
- 14. Patients with known or suspected liver failure. 15. Are female and pregnant, lactating, or planning to become pregnant during the study period.
- 16. Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months or previous enrollment in this study.
- 17. Patient has a condition the investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
- 18. Patient has an active malignancy of any type, or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
- 19. Patient has a known allergy or history of significant adverse reaction to trisodium citrate or related compounds or to any of the excipients (citric acid).
- 20. Any clinically significant abnormal laboratory test results found during medical screening, as determined by the investigator. NOTE: A test value above or below the normal range does not necessarily indicate that the value is "clinically significant." The determination should be made by the investigator.
- 21. Have a history of noncompliance with HD as assessed by an investigator. 22. Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
- 23. Are scheduled for living-donor transplantation within the study period, plan to change to peritoneal dialysis (PD) therapy within the study period, plan to change to a home HD treatment, or plan to relocate to an area where no study center is located.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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.
- Being tested
- Locking Solution
- Keywords
- Catheter Lock, Trisodium Citrate
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking SolutionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Locking Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Catheter Patency
Catheter Flow
Measured: 90 days
Secondary outcomes (1)
CRBSI
Incidence of catheter-related bloodstream infection (CRBSI) over the course of the study
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start23 Sep 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Enrollment was low or halted with few to zero future anticipated enrollments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Components, Inc dba MedComp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Veeva Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787926
- Sponsor's protocol ID
- 003
- Status last verified
- Jan 2024
- First submitted
- 4 Mar 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04787926
- Acronym / sponsor ID
- 003
- Keywords
- Catheter Lock, Trisodium Citrate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment was low or halted with few to zero future anticipated enrollments.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical Components, Inc dba MedCompIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Veeva Systems
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duralock-C 4% | – | Device: Locking SolutionDuraLock-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 |
| Duralock-C 30% | – | Device: Locking SolutionDuraLock-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 |
| Duralock-C 46.7% | – | Device: Locking SolutionDuraLock-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing hemodialysis (HD) via a central venous cathter (CVC).
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 1. Patients with an arteriovenous fistula or arteriovenous graft in use at the time of the study.
- 2. 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.
- 4. Patients with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
- 5. 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.
- 9. Patients using any type of antimicrobial-coated or heparin-coated catheter. 10. Have a positive serology test for human immunodeficiency virus or hepatitis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locking SolutionThe 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. | Device | Duralock-C 30%, Duralock-C 4%, Duralock-C 46.7% |
Primary outcome
Primary Catheter Patency
Time frame: 90 days
Catheter Flow
1 secondary outcome
CRBSI
Time frame: 90 Days
Results and safety
The study was stopped early (reason given: Enrollment was low or halted with few to zero future anticipated enrollments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided. Publication undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections and Citrate Adverse Reaction, run by Medical Components, Inc dba MedComp at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment was low or halted with few to zero future anticipated enrollments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Catheter Patency (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.