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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: Clinical Trial Phase 4 study, sponsored by Loma Linda University.
NCT00535821 is a Phase 4 study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
In-hospital mortality
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 |
Why NCT00535821 stopped before completion
NCT00535821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Esophageal Doppler monitoring - CardioQ, Deltex Inc is the first listed.
NCT00535821 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00535821's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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