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Anticoagulant

Sodium Citrate Locking Solution for Central Line Bloodstream Infection

Phase 4

Waitlist Available

Led By Darla Shores, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients (<18 years)

has had at least one central line-associated blood stream infection

Must not have

receiving continuous parenteral nutrition (infusing over 24 hours)

known cardiac arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test whether sodium citrate 4% can help prevent central line-associated blood stream infection (CLABSI) in children requiring long-term central venous catheters for home parenteral nutrition.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to sensitivity to citrate which could affect the heart or cause other symptoms. The safety profile will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 18 years old.

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I have had an infection from a central line.

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I need long-term IV nutrition because of severe gut issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a 24-hour IV nutrition plan.

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I have a known heart rhythm problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Central Line-associated Bloodstream Infection (CLABSI) Rate

Secondary study objectives

Central Line Removal Rate

Central Venous Catheter Thrombus Rate

Number of Serious Adverse Events

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 5Eligibility criteria met