← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am under 18 years old.
Select...
I have had an infection from a central line.
Select...
I need long-term IV nutrition because of severe gut issues.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central line-associated bloodstream infection (CLABSI) rate
Secondary outcome measures
Central line removal rate
Central venous catheter thrombus rate
Number of serious adverse events

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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,257 Previous Clinical Trials
14,820,091 Total Patients Enrolled
Darla Shores, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Sodium Citrate 4% (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04756427 — Phase 4
Central Line Bloodstream Infection Research Study Groups: Sodium citrate 4%
Central Line Bloodstream Infection Clinical Trial 2023: Sodium Citrate 4% Highlights & Side Effects. Trial Name: NCT04756427 — Phase 4
Sodium Citrate 4% (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04756427 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical ailment is Sodium Citrate 4% Inj Syringe 3Ml typically prescribed to treat?

"Sodium Citrate 4% Inj Syringe 3Ml is oftentimes used for surgical irrigation and has further applications in metabolic acidosis, plasmapheresis, and other medical treatments."

Answered by AI

Could you provide an overview of prior experiments involving Sodium Citrate 4% Inj Syringe 3Ml?

"Presently, there are four operational clinical trials testing Sodium Citrate 4% Inj Syringe 3Ml; one of these tests is in its final stage. Most of the research for this medication takes place in Los Angeles, California yet it has been researched at an additional four sites."

Answered by AI

Are there openings available in this clinical trial?

"The data posted on clinicaltrials.gov affirms that this trial, which was initially published on March 28th 2022, is not actively searching for participants at the present moment. However, there are 169 other studies recruiting patients presently."

Answered by AI

How hazardous is Sodium Citrate 4% Inj Syringe 3Ml to those receiving treatment?

"The safety of Sodium Citrate 4% Inj Syringe 3Ml is rated at a high 3 as this Phase 4 trial has been approved and thoroughly vetted."

Answered by AI

How many participants are currently registered for this trial?

"No, this clinical trial is not presently recruiting. Initially posted on March 28th 2022 and recently updated April 1st 2022, it does unfortunately seem to be inactive for the moment. However, there are currently 165 trials enrolling patients with central line associated blood stream infections (clabsi) and 4 studies admitting participants for Sodium Citrate 4% Inj Syringe 3Ml."

Answered by AI
Recent research and studies
~21 spots leftby Oct 2026