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KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure

NCT05879835 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-11-12

No results posted yet for this study

Summary

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).

Conditions

  • Pediatric Intestinal Failure

Interventions

DEVICE

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.

DEVICE

Heparin Lock Solution

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

Sponsors & Collaborators

  • Dicentra Inc.

    collaborator INDUSTRY

  • Meditrial SrL

    collaborator INDUSTRY

  • SterileCare Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Wales, MD · Cincinnati Children's

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05879835 on ClinicalTrials.gov