KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
NCT ID: NCT05879835
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2024-06-21
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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KiteLock 4% Sterile Catheter Lock Solution
4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.
KiteLock 4% Sterile Catheter Lock Solution
KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is nonpyrogenic. Tetrasodium salt of EDTA has been shown to disrupt in vivo and ex vivo-generated biofilms by destabilizing the structural integrity of micro-organisms at the cellular level.
Heparin Lock Solution
Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.
Heparin Lock Solution
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Interventions
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KiteLock 4% Sterile Catheter Lock Solution
KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is nonpyrogenic. Tetrasodium salt of EDTA has been shown to disrupt in vivo and ex vivo-generated biofilms by destabilizing the structural integrity of micro-organisms at the cellular level.
Heparin Lock Solution
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of intestinal failure defined as need for PN support for \>60 days in previous 74 days for primary intestinal disease (short bowel syndrome, primary motility disorder, mucosal enteropathy).
3. Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
4. Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
5. Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
6. Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC).
7. Clinical stability for at least 4 weeks and no acute medical comorbidities.
8. A minimum dwell time of 4 consecutive hours daily.
9. Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol.
Exclusion Criteria
2. Patients receiving long-term PN, but not due to a primary intestinal disorder (i.e., oncology patients or premature neonates on PN due to intestinal immaturity).
3. Known hypersensitivity, allergy, or reaction to EDTA.
4. Pregnancy or nursing mother.
5. Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial).
6. Severe coagulopathy (platelets \<50,000, or INR \> 1.5).
7. Diagnosis of immunodeficiency disorder.
8. Unstable medical condition requiring hospital admission
9. Received antibiotic therapy for CLABSI within last 14 days.
4 Weeks
18 Years
ALL
No
Sponsors
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Dicentra Inc.
INDUSTRY
Meditrial SrL
INDUSTRY
SterileCare Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Wales, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Children's
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Quirt J, Belza C, Pai N, Clause RF, Markovic F, Wong-Sterling S, Avitzur Y, Wales PW. Reduction of Central Line-Associated Bloodstream Infections and Line Occlusions in Pediatric Intestinal Failure Patients Receiving Long-Term Parenteral Nutrition Using an Alternative Locking Solution, 4% Tetrasodium Ethylenediaminetetraacetic Acid. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1286-1292. doi: 10.1002/jpen.1989. Epub 2020 Aug 30.
Other Identifiers
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CT23-001-SC001
Identifier Type: -
Identifier Source: org_study_id
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