KiteLock 4% EDTA for Pediatric Intestinal Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new solution to determine if it can better prevent clogs in the tubes used by children with intestinal failure who rely on total parenteral nutrition (TPN), a method of delivering nutrition directly into the bloodstream. The study compares a new catheter lock solution, KiteLock, containing 4% Tetrasodium EDTA, with the usual solution, heparin. Eligible children have been on TPN for more than 60 days due to primary intestinal diseases like short bowel syndrome and have a stable routine that allows them to manage TPN at home. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance home care for children on TPN.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KiteLock 4% EDTA Lock Solution is safe to use. Studies indicate it reduces complications by about 50% compared to standard heparin locks. This is encouraging, particularly because it lacks preservatives or antibiotics, which can sometimes cause reactions. The solution also helps combat bacteria.
Regarding side effects, data has not shown any major issues, suggesting it is well-tolerated by patients. For those considering joining this trial, the safety evidence appears promising.12345Why are researchers excited about this trial's treatments?
KiteLock 4% Sterile Catheter Lock Solution is unique because it uses tetrasodium EDTA, which acts as an anticoagulant and antimicrobial agent, potentially reducing the risk of catheter occlusions and infections. Unlike the standard heparin lock solutions, which primarily focus on preventing blood clots, KiteLock aims to also tackle microbial growth, offering a dual-action approach. Researchers are excited about this treatment because it could provide a safer option for children with intestinal failure, especially those who are most vulnerable due to their young age and small size.
What evidence suggests that this trial's treatments could be effective in preventing catheter occlusions in children with intestinal failure?
Research has shown that the KiteLock 4% EDTA lock solution, tested in this trial, effectively keeps catheters open and free from blockages. It prevents blood clots and fights bacteria, reducing infections and blockages in the catheter. Some studies found the 4% EDTA solution more effective than both taurolidine and heparin, and it also costs less. Evidence from studies with children demonstrated fewer catheter-related infections without increasing other complications. These findings suggest that KiteLock 4% could be a good option for children needing long-term catheter use. Meanwhile, another arm of this trial will use the Heparin lock solution, administered daily per investigator judgment, due to its significant clinical risk in the youngest, smallest, and most vulnerable subjects.24678
Who Is on the Research Team?
Paul Wales, MD
Principal Investigator
Cincinnati Children's
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment completed at recruitment to the study
Treatment
Participants receive either Heparin or KiteLock 4% EDTA lock solution
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KiteLock 4% EDTA Lock Solution
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.
Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SterileCare Inc.
Lead Sponsor
Dicentra Inc.
Industry Sponsor
Meditrial SrL
Industry Sponsor
Citations
Compassionate-Use of 4% T-EDTA Lock Solution for ...
4% Tetrasodium-EDTA lock solution is known to improve catheter patency by working as an in vitro anticoagulant with in vitro antimicrobial activity against ...
Control of Line Complications with KiteLock (CLiCK) in the ...
A multi-center, cluster-randomized, crossover trial evaluating the impact of 4% tetrasodium EDTA on a primary composite outcome of the incidence rate of ...
KiteLock4%™ Sterile Catheter Lock Solution
Summary: 4% Tetrasodium EDTA was dominant (more effective and less expensive) compared to taurolidine and heparin with savings of CAD $88,277 compared to ...
WCN24-634 SAFETY AND PRACTICAL USE OF 4% ...
In pediatric HD patients, CVL locking with Kitelock™ has resulted in a sustained unit-level reduction in CLABSI incidence, without an increase in the incidence ...
5.
journals.lww.com
journals.lww.com/journalofinfusionnursing/fulltext/2024/07000/implementing_a_4__edta_central_catheter_locking.7.aspxImplementing a 4% EDTA Central Catheter Locking ...
Studies suggest that 4% EDTA may be the only locking solution capable of preventing CVAD-related infections, coagulation, and biofilm with extreme efficiency.
Use of 4% tetrasodium EDTA (KiteLock™) to prevent ...
Unlike standard locking solutions, 4% tetrasodium EDTA (KiteLock™) has antimicrobial and antibiofilm properties. We aimed to study the safety ...
KiteLock 4% EDTA Lock Solution for the Prevention of ...
KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is ...
8.
assets.cdn.thewebconsole.com
assets.cdn.thewebconsole.com/S3WEB4798/images/62578f927ed03.pdf?m=381b71b8ae1a202cebfc27362eceb748SUMMARY OF SAFETY PROFILE KiteLock™ 4% Sterile ...
KiteLock™ 4% Sterile Catheter Lock Solution becomes ineffective as an antimicrobial agent in vivo as it immediately binds to circulating calcium ...
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