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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a sodium citrate solution in preventing infections in children with central lines, which are special tubes used for nutrition. It targets children requiring long-term home nutrition due to serious gut issues like short bowel syndrome. The trial will assess the solution's ability to prevent central line infections and monitor for any side effects. Children who have previously experienced these infections and need at least three months of home parenteral nutrition may be suitable candidates. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for sodium citrate 4%?

Research has shown that sodium citrate 4% is generally safe for use in catheters, helping to prevent blockages, bleeding, and infections. It has been safely used in children with dialysis catheters, which resemble the central lines used for nutrition.

Sodium citrate 4% does not increase bleeding risk or affect blood clotting. In Europe, it has been used as a catheter lock without major issues. This suggests that sodium citrate 4% is well-tolerated and effective in preventing infections in central lines. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Sodium citrate 4% is unique because it offers a different approach to preventing central line-associated bloodstream infections (CLABSI). Unlike traditional anticoagulant or antibiotic locks, sodium citrate acts as an anticoagulant and has antimicrobial properties, which can help reduce the risk of infection without contributing to antibiotic resistance. Researchers are excited about this treatment because it could provide a safer and more effective alternative, potentially minimizing complications and improving patient outcomes.

What evidence suggests that sodium citrate 4% might be an effective treatment for preventing central line-associated bloodstream infections?

Research has shown that sodium citrate 4% can help prevent infections in catheters. Earlier studies found it stops infections by blocking the growth of bacterial layers, known as biofilm, on catheters. Sodium citrate 4% also serves as a safe and effective alternative to heparin for use in dialysis catheters, which are similar to those used for intravenous feeding. This treatment is already approved for dialysis catheters, and its success in reducing infections makes it a promising option for preventing bloodstream infections in children with central lines. In this trial, all participants will receive the daily sodium citrate 4% locking solution for CLABSI prophylaxis and be observed for adverse events. ^{1 3 6 7 8}

Who Is on the Research Team?

Darla Shores, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10317237/

Clinical application of 4% sodium citrate and heparin in the ... The used outcome indicators include: four indexes of blood coagulation at 10 minutes after locking and 7 d after the first locking, bleeding ...

2. researchgate.net researchgate.net/publication/6731329_Sodium_citrate_4_locking_solution_for_central_venous_dialysis_catheters-An_effective_more_cost-efficient_alternative_to_heparin

Sodium citrate 4% locking solution for central venous ... In addition, citrate has been reported to prevent biofilm production 11 , reduce catheter-related bloodstream infection 12,13 , reduce bleeding ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1530619/full

Citrate as a safe and effective alternative to heparin for ... Catheter-related bloodstream infection (CRBSI), catheter-related infection (CRI), exit-site infection (ESI), and adverse events were analyzed.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04756427/Prot_SAP_000.pdf

Sodium Citrate 4% Locking Solution for Children Requiring ... Sodium citrate 4% has been safe and effective for use in children with dialysis catheters, which are very similar to the central catheters used ...

5. journals.asm.org journals.asm.org/doi/10.1128/aac.00254-16

In Vitro Assessment of the Antimicrobial Efficacy of Optimized ... This study reported a significant reduction in catheter-related bloodstream infections (CRBSIs) with the use of taurolidine-citrate-heparin (0.1 CRBSIs per ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6753535/

Reducing catheter-associated complications using 4% sodium ... The solution 4% sodium citrate can effectively reduce the risk of catheter obstruction, bleeding, infection, and leakage better than sodium heparin.

7. withpower.com withpower.com/trial/phase-4-sepsis-9-2021-5e4d6

Sodium Citrate Locking Solution for Central Line ... 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 ...

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT04756427/

Trial | NCT04756427 This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing ...