TerminatedPhase 4

Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

Stopped: Subject recruitment was challenging

United States1 participantsStarted 2022-03-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pediatric patients (\<18 years) and adult patients (up to 21 years still in our clinic) * requiring long-term (\>3 months) home parenteral nutrition due to intestinal failure/short bowel syndrome * has had at least one central line-associated blood stream infection Exclusion Criteria: * known cardiac arrhythmias * hypersensitivity to citrate * pregnancy * receiving continuous parenteral nutrition (infusing over 24 hours)

What they're measuring

Central Line-associated Bloodstream Infection (CLABSI) Rate

Timeframe: 12 months

Trial details

NCT IDNCT04756427

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-28

Results submitted2024-08-09

View on ClinicalTrials.gov More CLABSI - Central Line Associated Bloodstream Infection trials