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

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Anticoagulants; Citric Acid; Sodium Citrate

Criteria

Inclusion Criteria:

• Pediatric patients (<18 years)

• 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)