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NCT04756427 · ClinicalTrials.gov registry record · Phase 4
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
A Phase 4 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT04756427: Clinical Trial Phase 4 study, sponsored by Johns Hopkins University.
NCT04756427 is a Phase 4 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04756427, a Phase 4 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
Frequency of fever with positive central line blood culture events per central line days.
Interventions
- DRUG Sodium Citrate 4% Inj Syringe 3Ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2023-11-28 |
| Phase | Phase 4 |
Why NCT04756427 stopped before completion
NCT04756427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Citrate 4% Inj Syringe 3Ml is the first listed.
NCT04756427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04756427 about?
NCT04756427 is a clinical study titled "Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition". 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 citrat...
What is the current status of trial NCT04756427?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2022-03-28. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT04756427?
The interventions under investigation include: Sodium Citrate 4% Inj Syringe 3Ml (DRUG).
Who is sponsoring clinical trial NCT04756427?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04756427's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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