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NCT03340805 · ClinicalTrials.gov registry record · Phase 1
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
A Phase 1 study of Shock, Septic, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03340805 is a Phase 1 study of Shock, Septic that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03340805, a Phase 1 study of Shock, Septic, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility assessments include ensuring appropriate compliance with study fluid in each of the two arms, effectiveness of study enrollment using a pragmatic study design embedded within routine clinical practice, and acceptability of using Exception from Informed Consent (EFIC).
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Lactated Ringer
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03340805
The ClinicalTrials.gov registry entry for NCT03340805 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 1 condition, with Shock, Septic appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT03340805 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03340805 about?
NCT03340805 is a clinical study titled "Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study". The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility assessments include ens...
What is the current status of trial NCT03340805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-01-24. Estimated completion is 2019-01-15.
What conditions does trial NCT03340805 study?
This clinical trial studies the following conditions: Shock, Septic.
What interventions are being tested in trial NCT03340805?
The interventions under investigation include: Normal saline (DRUG), Lactated Ringer (DRUG).
Who is sponsoring clinical trial NCT03340805?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03340805 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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