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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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2026-06-30

Brief Summary

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A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).

Detailed Description

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A total of 124 (62 per arm) will be enrolled into the study. Screening and informed consent (and assent if applicable) will be obtained prior to study procedures. The baseline assessment will be completed at recruitment to the study. Once the baseline assessment is complete and eligible subjects are randomized, the study drug will be dispensed per protocol. The study follow-up period will be 52 weeks. Four follow-up clinical in-person visits will occur at 2,12, 28, 40 and 52 weeks. Visits will be conducted by physicians or nurse practitioners. The study visits will assess general status, study bloodwork, adverse events, catheter patency, alteplase use, infection assessment, catheter integrity, and provide investigational product. Telephone follow up will occur on day-3 of intervention, and once per 4 weeks, as well as in the event of outpatient care/hospital admission, or safety event. Subject daily diaries will be utilized for detailed monitoring. Diary recordings will include adverse events, including occlusive events, and any subject specific details (e.g. dwell times, heparin flushing vs. aspiration) or issues in the delivery of the study locking solutions.

Conditions

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Pediatric Intestinal Failure

Keywords

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catheter lock solution pediatric intestinal failure intestinal failure central venous catheter KiteLock 4% heparin total parenteral nutrition parenteral nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multisite, randomized, open-label, 2-arm parallel-group superiority trial
Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

KiteLock 4% Sterile Catheter Lock Solution

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Heparin Lock Solution

Intervention Type DEVICE

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.

Intervention Type DEVICE

Heparin Lock Solution

Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients managed by the intestinal rehabilitation program at one of the participating centers.
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

1. A temporary CVC (jugular or femoral) or peripheral catheter.
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.
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dicentra Inc.

INDUSTRY

Sponsor Role collaborator

Meditrial SrL

INDUSTRY

Sponsor Role collaborator

SterileCare Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status NOT_YET_RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Cook Children's Health Care System

Fort Worth, Texas, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joanne Greco

Role: CONTACT

Phone: 6472006232

Email: [email protected]

Facility Contacts

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Jaeson Kim

Role: primary

Zainab Hussein

Role: backup

Jill Povondra

Role: primary

Michelle Leahy

Role: backup

Candido Batres, MD, CCRC

Role: primary

Kennesha M Bragg, MS

Role: primary

Crystal Slaughter, BA, CCCR

Role: primary

Kim Klotz, MSN, RN, CNRI

Role: backup

Kaitlyn Brown, RN, BSN

Role: primary

Brittany Simpson

Role: primary

Alexis Gossett

Role: backup

Teresa Chen

Role: primary

Melissa Young

Role: backup

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.

Reference Type BACKGROUND
PMID: 32770561 (View on PubMed)

Other Identifiers

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CT23-001-SC001

Identifier Type: -

Identifier Source: org_study_id