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Could a simple lock solution prevent dangerous line infections in kids?

NCT ID NCT04559334

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 4% T-EDTA lock solution (KiteLock™) in 15 children aged 3 months to 18 years who have a central line for IV nutrition. The solution is placed into the line when not in use to prevent blood clots and infections. Researchers will track side effects, line blockages, breaks, and infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tetrasodium EDTA (KiteLock™ 4% Sterile Catheter Lock Solution)
What this could lead to
If it works, this could offer a safer way to keep central lines working and reduce infections in children who need long-term IV nutrition.
What could go wrong
This is a very small, early study (15 participants) that is currently suspended. The solution may cause side effects or fail to prevent clots or infections better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

15 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. Patients aged 3 months to 18 years old inclusive 3. Minimum patient weight of at least 5 kilograms 4. History of at least one thrombolytic occlusion and/or CLABSI event 5. Signed patient informed consent 6. Clinically stable for at least 4 weeks with no acute medical co-morbidities Exclusion Criteria: 1. Pregnancy or nursing mother 2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial) 3. The parent or guardian or child unwilling to provide consent or assent 4. 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 5. Subjects who are hypersensitive or allergic to EDTA 6. Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth) 7. A compromised catheter defined as one which has been repaired several times.

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Conditions

The condition(s) this trial relates to.

chronic intestinal failure Hyperphagia Intestinal Failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central line complication Central line-associated bloodstream infection (clabsi)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Childrens's Hospital Boston

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.