NCT00535821

Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock

A Multi-center Randomized Comparison of a Minimally-invasive Cardiovascular Hemodynamic Optimization (MiCHO) Protocol Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock Patients Presenting to the Emergency Department

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DEVICE	Esophageal Doppler monitoring - CardioQ, Deltex Inc	6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
DEVICE	Central line with CVP and continuous ScvO2 monitoring	6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-09-26
• Last updated: 2014-06-25
• Results posted: 2014-06-25

Locations

4 sites across 1 country: United States