KiteLock for Preventing Catheter Occlusions in Children with Intestinal Failure

This study is looking at whether a solution called KiteLock 4% Sterile Catheter Lock Solution can better prevent blockages (occlusions) in central venous catheters compared to the standard Heparin Lock Solution. These catheters are used to provide nutrition (total parenteral nutrition or TPN) to children with intestinal failure. The study will include 124 children, aged 4 weeks to 18 years, who need TPN for at least 60 days due to intestinal failure. The main goal is to see how many catheter occlusions happen over 52 weeks in each group. The current status of this study is unclear.

Study design
This is a multi-site, randomized, open-label study, meaning participants are randomly assigned to one of two groups, and both you and your doctors will know which treatment you are receiving. A total of 124 participants will be enrolled.
What's involved
You would have an initial assessment, then receive the assigned lock solution for 52 weeks. There will be five in-person clinic visits at 2, 12, 28, 40, and 52 weeks, plus phone calls on day 3 and every 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 52 weeks after starting the study treatment.

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NCT05879835

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

Recruiting
NAAges 4–18InterventionalPrevention
SterileCare Inc.
~124 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:KiteLock 4% Sterile Catheter Lock SolutionHeparin Lock Solution

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of catheter occlusions
Measured over 52 weeks
Pediatric Intestinal Failure
8 sites across 7 states
Ohio2
Massachusetts1
Nebraska1
New York1
North Carolina1
Texas1
Washington1
  • Paul Wales, MD · PRINCIPAL_INVESTIGATOR · Cincinnati Children's

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  • Incidence of catheter occlusions52 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.