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RECRUITING
NCT05879835
NA

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

Sponsor: SterileCare Inc.

View on ClinicalTrials.gov

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).

Official title: Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children With Intestinal Failure: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

4 Weeks - 18 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-06-21

Completion Date

2026-06

Last Updated

2025-11-12

Healthy Volunteers

No

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.

Locations (8)

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