EDTA Lock Solution for Central Line Infection

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

AN

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

My health has been stable for the last 4 weeks without any new serious illnesses.
I have had a blood clot or an infection from an IV line before.
I have a special tube inserted for nutrition or hydration due to intestinal failure.
See 2 more

Exclusion Criteria

You are pregnant or breastfeeding.
Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
I do not have any current severe health issues like heart attack, stroke, or severe infections.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4%) to maintain catheter patency and prevent complications

12 months
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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

Group I: open labelExperimental Treatment1 Intervention

Tetrasodium EDTA is already approved in Canada, European Union for the following indications:

🇨🇦
Approved in Canada as KiteLock™ 4% for:
🇪🇺
Approved in European Union as KiteLock™ 4% for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

SterileCare Inc.

Industry Sponsor

Trials
3
Recruited
1,600+

SterileCare Inc.

Collaborator

Trials
2
Recruited
1,500+

Citations

Use 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 ...

KiteLock 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 ...

Tetrasodium 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.

Hill - 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 ...

the 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 ...

4% t-EDTA Reduces CVAD Infections in ICU Patients

4% tetrasodium EDTA was associated with significantly reduced CVC-related infections and improved CVC patency.

Use 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 ...