Purpose of this Study
Some kids need a special tube called a central line to get medicine and food. But when the tube isn’t being used, it can get blocked or infected. To help stop this, doctors use a liquid called a locking solution.
In this study, kids will be randomly placed into one of two groups:
- Group 1 will use the regular locking liquid called heparin.
- Group 2 will use a new liquid called Kitelock.
Both groups will use their locking liquid every day. They’ll also have check-ups, blood tests, and keep a daily diary. The study will last about 1 year and include 6 in-person visits and 10 phone or video visits.
Who Can Participate?
Eligibility
Who can join this study:
- Kids who have a serious stomach problem called intestinal failure and need special nutrition through a tube.
- They must be older than 4 weeks but were diagnosed before turning 18.
- They must have a special kind of tube called a central line, which helps give them medicine and nutrients.
Age Range
0-18
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
Doctors are doing a study to learn more about a new liquid called KiteLock. It’s used to keep special tubes (called central lines) clean and safe for kids who have serious stomach problems and need help getting food and medicine.
KiteLock has something called tetrasodium EDTA in it, and doctors want to see if it works better than the regular liquid called heparin. The goal is to find out which one helps stop clogs and infections in the tubes more safely and effectively.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full 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
Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children
with Intestinal Failure: A Randomized Controlled Trial
Principal Investigator
Debra
Sudan
Protocol Number
PRO00118105
Enrollment Status
Pending Open to Enrollment