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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 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 9,041 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04102371
The ClinicalTrials.gov registry entry for NCT04102371 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9,041 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT04102371 reports 0 study locations.
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.
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