Trial Summary
What is the purpose of this trial?This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long term central venous catheters for home parenteral nutrition. Sodium citrate 4% is FDA-approved for dialysis catheters, but has not been formally evaluated for use in tunneled catheters for parenteral nutrition. The rate of central line-associated bloodstream infection (CLABSI) and other potential adverse events will be monitored for 12 months, with the option to remain in the study for a longer period of time.
Eligibility Criteria
This trial is for children under 18 who need long-term nutrition directly into their veins at home due to intestinal issues and have had a previous infection from their central line. It's not for kids with citrate allergies, heart rhythm problems, those on non-stop nutrition infusions, or who are pregnant.Inclusion Criteria
I am under 18 years old.
I have had an infection from a central line.
I need long-term IV nutrition because of severe gut issues.
Exclusion Criteria
I am on a 24-hour IV nutrition plan.
I have a known heart rhythm problem.
hypersensitivity to citrate
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Participant Groups
The study is testing if Sodium Citrate 4% can prevent infections in the bloodstream caused by long-term central venous catheters used for feeding at home. This solution is approved for dialysis but hasn't been fully studied for this particular use yet.
1Treatment groups
Experimental Treatment
Group I: Sodium citrate 4%Experimental Treatment1 Intervention
All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor