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NCT00535821 · ClinicalTrials.gov registry record · Phase 4
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
A Phase 4 study, sponsored by Loma Linda University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT00535821 is a Phase 4 study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 5 participants.
The verdict
NCT00535821, a Phase 4 study, was terminated before completion, sponsored by Loma Linda University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Early intervention in the treatment of septic shock, including early goal-directed therapy (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its widespread application in the emergency department setting. A minimally invasive protocol utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown to result in similar outcome as EGDT.
Interventions
- DEVICE Esophageal Doppler monitoring - CardioQ, Deltex Inc
- DEVICE Central line with CVP and continuous ScvO2 monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00535821
The ClinicalTrials.gov registry entry for NCT00535821 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Esophageal Doppler monitoring - CardioQ, Deltex Inc is the first listed.
NCT00535821 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00535821 about?
NCT00535821 is a clinical study titled "Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock". Early intervention in the treatment of septic shock, including early goal-directed therapy (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its widespread applicatio...
What is the current status of trial NCT00535821?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2007-06. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00535821?
The interventions under investigation include: Esophageal Doppler monitoring - CardioQ, Deltex Inc (DEVICE), Central line with CVP and continuous ScvO2 monitoring (DEVICE).
Who is sponsoring clinical trial NCT00535821?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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