KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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).
Eligibility
Primary outcome measure(s)
- Incidence of catheter occlusions — 52 weeks
Occlusion is defined as requiring chemical or surgical intervention to restore patency. Occlusion rates will be pooled for each study arm and reported per 1000 catheter days.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Not Yet Recruiting |
| Nyph/Cumc | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | Recruiting |
| Cook Children's Health Care System | Fort Worth | Texas | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05879835 on ClinicalTrials.gov ↗ ← All trials in the USA