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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
At a glance
Conditions
Where it's being run
8 sites across 7 statesStudy leadership
- Paul Wales, MD · PRINCIPAL_INVESTIGATOR · Cincinnati Children's
Who to contact
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What this trial measures
- 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.