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Chelating Agent

EDTA Lock Solution for Central Line Infection

N/A
Waitlist Available
Led By Mark Puder, MD, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically stable for at least 4 weeks with no acute medical co-morbidities
Presence of a tunneled central venous catheter or peripherally inserted central catheter (PICC) for administration of PN or intravenous hydration fluids to treat intestinal failure
Must not have
Clinical instability such as the following: Acute pulmonary edema, Acute myocardial infarction, Acute stroke, Acute thromboembolism, Metabolic acidosis, Sepsis, Coagulopathy with prolonged activated partial thromboplastin time (aPTT) or international normalized ratio (INR), Severe hypoglycemia, Subjects who are hypersensitive or allergic to EDTA, Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth), A compromised catheter defined as one which has been repaired several times.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a daily dose of tetrasodium sodium EDTA can reduce the risk of central line-associated bloodstream infection without increasing the risk of catheter breakage.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include local reactions at the site where the catheter enters the body and possible hypersensitivity reactions if there's an allergy to EDTA. There might also be risks not yet known due to its investigational status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health has been stable for the last 4 weeks without any new serious illnesses.
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I have a special tube inserted for nutrition or hydration due to intestinal failure.
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I have had a blood clot or an infection from an IV line before.
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I am between 3 months and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any current severe health issues like heart attack, stroke, or severe infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Number of Participants with Catheter Breaks
The Number of Participants with Catheter Occlusions
Therapeutic procedure
Secondary study objectives
The Number of Central Line Associated Bloodstream Infections (CLABSIs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: open labelExperimental Treatment1 Intervention
All participants will receive Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4% Sterile Catheter Lock Solution)

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
783 Previous Clinical Trials
5,581,231 Total Patients Enrolled
SterileCare Inc.Industry Sponsor
2 Previous Clinical Trials
1,648 Total Patients Enrolled
Mark Puder, MD, PhDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

Central Line Infection Research Study Groups: open label
~11 spots leftby Dec 2025
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