EDTA Lock Solution for Central Line Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a solution called Tetrasodium EDTA (Kitelock™) to keep central venous catheters clear and infection-free. Central line-associated bloodstream infections (CLABSIs) can occur when catheters become blocked, so this solution aims to prevent blockages without causing issues like catheter breakage. The trial is open to children with a central venous catheter for nutrition or hydration who have a history of catheter blockages or CLABSIs. Participants must have been stable for at least four weeks with no other serious health issues. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance catheter care for many patients.
What prior data suggests that this solution is safe for maintaining central line patency?
Research has shown that the 4% tetrasodium EDTA lock solution, known as KiteLock™, is generally safe for patients. Studies have found that this solution outperforms heparin, a common treatment, in maintaining catheter function and reducing infections. One study revealed that patients using KiteLock™ experienced fewer catheter-related bloodstream infections, with some cases showing a complete reduction.
No serious medical issues arose during at least four weeks of use, indicating that the treatment remains stable and safe for regular use. The solution also helps keep the catheter open and functioning properly.
Overall, these findings support the safety and effectiveness of tetrasodium EDTA in maintaining the health of central venous catheters.12345Why are researchers excited about this trial?
Unlike most treatments for central line infections that typically involve antibiotics, the Tetrasodium EDTA Lock Solution, known as KiteLock™ 4%, offers a novel approach. This treatment acts as a catheter lock solution, which means it's directly administered into the catheter to help prevent infections. Researchers are excited about this because it uses Tetrasodium EDTA, a compound known for its ability to chelate metals and disrupt bacterial biofilms, potentially preventing infection without contributing to antibiotic resistance. This innovative approach could lead to fewer complications and better outcomes for patients with central lines.
What evidence suggests that this treatment might be an effective treatment for central line infection?
Research has shown that a 4% solution of tetrasodium EDTA, known as KiteLock, can help keep central venous catheters clear and reduce infection risk. Studies have found it more effective than heparin in preventing blockages in children's catheters. This solution also combats biofilms, which are clusters of bacteria that adhere together and cause infections. It has proven effective against various bacteria and fungi, common culprits of infections. Overall, tetrasodium EDTA appears promising for reducing both blockages and infections in catheters. All participants in this trial will receive the Tetrasodium EDTA Catheter Lock Solution.15678
Who Is on the Research Team?
Alexandra N Carey, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric patients aged 3 months to 18 years, weighing at least 5 kg, with a central venous catheter used for nutrition or hydration due to intestinal failure. They must have had previous catheter blockages or infections but be stable health-wise for the past month. Those on other trials, unstable conditions, allergic to EDTA, on certain long-term antibiotics, with compromised catheters or pregnant/nursing cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4%) to maintain catheter patency and prevent complications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tetrasodium EDTA
Trial Overview
The study tests Tetrasodium EDTA (Kitelock™) as a daily lock solution in central venous catheters of children receiving parenteral nutrition. The goal is to maintain blood flow and prevent infections associated with these lines without causing additional complications like catheter breakage.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will receive Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4% Sterile Catheter Lock Solution)
Tetrasodium EDTA is already approved in Canada, European Union for the following indications:
- Prevention of central line-associated bloodstream infections (CLABSI)
- Prevention of catheter occlusions
- Prevention of central line-associated bloodstream infections (CLABSI)
- Prevention of catheter occlusions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
SterileCare Inc.
Industry Sponsor
SterileCare Inc.
Collaborator
Citations
1.
trial.medpath.com
trial.medpath.com/clinical-trial/d109c6564a6165d5/nct04067245-tetrasodium-edta-catheter-lock-home-parenteral-nutritionUse of Tetrasodium EDTA Catheter Lock... | Clinical Trial
One recently developed solution, tetrasodium EDTA, aims to reduce both thrombosis and infection. This scientific review provides an overview of ...
KiteLock Study Protocol - Full Text
Four percent of tetrasodium ethylenediaminetetraacetic acid (EDTA) fluid (marketed as KiteLock Sterile Locking Solution™) is non-antibiotic, possesses ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05879835/kitelock-4-edta-lock-solution-for-the-prevention-of-occlusions-in-children-with-intestinal-failureKiteLock 4% EDTA Lock Solution for the Prevention of ...
4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock in preventing central venous catheter occlusions in children ...
4.
researchgate.net
researchgate.net/publication/7727087_Tetrasodium_EDTA_as_a_Novel_Central_Venous_Catheter_Lock_Solution_Against_BiofilmTetrasodium EDTA as a Novel Central Venous Catheter ...
This study tested the efficacy of tetrasodium EDTA as a catheter lock solution on biofilms of several clinically relevant microorganisms.
5.
gavecelt.it
gavecelt.it/nuovo/sites/default/files/uploads/Hill%20-%20Solutions%20for%20catheter%20lock.pdfHill - Solutions for catheter lock.pptx
There is evidence to support the strategy of T-EDTA 4% for a lock solution to combat the Triple Threat of occlusion, bacterial colonization and biofilm ...
6.
gavecelt.it
gavecelt.it/nuovo/sites/default/files/uploads/Belza%20-%20Lock%20antimicrobico%20non%20antibiotico.pdfthe non-antibiotic antimicrobial lock
EDTA Time to kill: Safety Profile of Kitelock 4% Sterile Catheter Lock Solution mg/kg. History of line infections or recurrent blockages. Instill 1 ml at end ...
7.
linkedin.com
linkedin.com/posts/sterilecare-inc_criticalcare-icu-vascularaccess-activity-7462303531086290944-SOTh4% t-EDTA Reduces CVAD Infections in ICU Patients
4% tetrasodium EDTA was associated with significantly reduced CVC-related infections and improved CVC patency.
8.
clinicaltrial.be
clinicaltrial.be/en/details/61808?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1¬_yet_recruiting=0&completed=0&only_eligible=0Use of Tetrasodium EDTA Catheter Lock Solution for Patien...
Antibiotic lock solutions have been used for salvage of central venous catheters in confirmed CRBSI. However, it is not recommended as a primary ...
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