Sodium Citrate Locking Solution for Central Line Bloodstream Infection

Overseen By Darla Shores, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Disqualifiers: Cardiac arrhythmias, Hypersensitivity to citrate, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is sodium citrate locking solution safe for use in humans?

Sodium citrate is generally considered safe when used as a catheter lock at appropriate concentrations, such as 4%, and has been used in Europe without major complications. However, using highly concentrated solutions improperly can lead to serious adverse outcomes, as seen in one case where misuse led to a safety warning. ^{1 2 3 4 5}

How does the drug sodium citrate 4% differ from other treatments for preventing central line bloodstream infections?

Sodium citrate 4% is unique because it has both antibacterial and anticoagulant properties, which help prevent infections and bleeding complications when used as a catheter lock, unlike traditional heparin that primarily acts as an anticoagulant and may have more adverse effects. ^{1 2 5 6 7}

Research Team

Darla Shores, MD

Principal Investigator

Johns Hopkins University

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily sodium citrate 4% locking solution for CLABSI prophylaxis

12 months

Monthly outpatient follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of sodium citrate 4% locks after the initial study period if no serious adverse events have occurred

Long-term

Treatment Details

Interventions

• Sodium Citrate 4%

Trial Overview 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.

Participant Groups

Group I: Sodium citrate 4% Experimental Treatment 1 Intervention

All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Sodium citrate versus heparin catheter locks for cuffed central venous catheters: a single-center randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical application of 4% sodium citrate and heparin in the locking of central venous catheters (excluding dialysis catheters) in intensive care unit patients: A pragmatic randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Concentrated sodium citrate catheter lock: "The best laid schemes o' mice an' men…". [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sodium citrate versus saline catheter locks for non-tunneled hemodialysis central venous catheters in critically ill adults: a randomized controlled trial. [2021]

6. Poland pubmed.ncbi.nlm.nih.gov

[The impact of sodium citrate on dialysis catheter function and frequency of catheter-related bacteriemia and haemorrhage]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Citrate versus heparin for apheresis catheter locks: an efficacy analysis. [2015]