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

Stopped early · Phase 4

Conditions studied: Severe Sepsis, Septic Shock

In brief

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.

Key facts

Study ID

NCT00535821

Run by

Loma Linda University

People needed

5

Starts

2007-06-01

Expected to finish

2010-09-01

Last updated by the study team

2014-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients >= 18 years old
• Source of infection
• Two or more of systemic inflammatory response syndrome criteria
• Systolic blood pressure < 90 mmHg after a fluid bolus OR lactate >= 4 mmol/L
• A central line has been placed for CVP/ScvO2 monitoring

You may not qualify if…

• Pregnancy
• Acute stroke
• Acute cardiogenic pulmonary edema
• Status asthmaticus
• Unstable cardiac dysrhythmia
• Active hemorrhage
• Acute seizure
• Drug overdose
• Trauma
• Requiring immediate surgery
• Do-not-resuscitate status

Where it is running

• Loma Linda University — Loma Linda, California, United States
• VA Loma Linda Health Care System — Loma Linda, California, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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