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NCT04102371 · ClinicalTrials.gov registry record · Phase 3
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis
A Phase 3 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 3
- Development phase
- 9,041
- Enrollment target
NCT04102371: Completed Phase 3 study, sponsored by Children's Hospital of Philadelphia.
NCT04102371 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 9,041 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1073% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04102371, a Phase 3 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9,041 participants
- Enrollment target
Study Summary
The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.
Primary Outcome
A composite of death, initiation of new inpatient renal replacement therapy (RRT), or persistent kidney dysfunction, at 30 days following study enrollment or hospital discharge, whichever comes first.
Interventions
- DRUG Normal Saline
- DRUG Lactated Ringer
- DRUG Plasma-lyte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,041 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 3 |
What the finished NCT04102371 record still lists
NCT04102371 is an interventional study that assigns participants to a tested intervention. Its 9,041 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1073% higher).
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT04102371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04102371 about?
NCT04102371 is a clinical study titled "Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis". The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.
What is the current status of trial NCT04102371?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9,041 participants. The study started on 2020-08-25. Estimated completion is 2026-01-31.
What interventions are being tested in trial NCT04102371?
The interventions under investigation include: Normal Saline (DRUG), Lactated Ringer (DRUG), Plasma-lyte (DRUG).
Who is sponsoring clinical trial NCT04102371?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04102371's enrollment target sits among peer trials
9,041 31st of 2000 higher than 1,970 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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