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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Number of Participants with Catheter Breaks

The Number of Participants with Catheter Occlusions

Therapeutic procedure

Secondary outcome measures

The Number of Central Line Associated Bloodstream Infections (CLABSIs)

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)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

760 Previous Clinical Trials

5,579,630 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment currently gathering participants?

"Clinicaltrials.gov shows that this trial, which was initially posted on December 21st 2020 and last updated February 9th 2022, is not currently open for recruitment. However, there are still 165 other studies actively seeking participants at the moment."

Answered by AI

Is the age eligibility for this trial restricted to individuals 35 years or older?

"To participate in this trial, applicants must be between 3 months and 18 years old. There are 33 studies for minors and 140 for the elderly population over 65 years of age."

Answered by AI

Who qualifies to take part in this clinical research?

"This research trial is enrolling a cohort of 50 individuals with central line issues, between the ages of 3 months and 18 years. The primary criteria for admission are: weight no less than 5 kilograms, age range from 3 months to 18 years old inclusively, and clinical stability for at least 4 weeks without acute medical conditions."

Answered by AI

Recent research and studies

MedicineJournal

A Review of Risk Factors for Catheter-related Bloodstream Infection Caused by Percutaneously Inserted, Noncuffed Central Venous Catheters

SAFDAR, NASIA, DANIEL M. KLUGER, and DENNIS G. MAKI. 2002. “A Review of Risk Factors for Catheter-related Bloodstream Infection Caused by Percutaneously Inserted, Noncuffed Central Venous Catheters”. Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005792-200211000-00007.

The Journal of PediatricsJournal

Natural History of Pediatric Intestinal Failure: Initial Report from the Pediatric Intestinal Failure Consortium

Squires, Robert H., Christopher Duggan, Daniel H. Teitelbaum, Paul W. Wales, Jane Balint, Robert Venick, Susan Rhee, et al.. 2012. “Natural History of Pediatric Intestinal Failure: Initial Report from the Pediatric Intestinal Failure Consortium”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2012.03.062.

Clinical NutritionJournal

What Information Should Lead to a Suspicion of Catheter Sepsis in HPN?

Clare, Anna, Antje Teubner, and Jon L. Shaffer. 2008. “What Information Should Lead to a Suspicion of Catheter Sepsis in HPN?”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2008.04.013.

Thrombosis ResearchJournal