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

Phase 4

Terminated

• Conditions: Septic Shock; Severe Sepsis
• Interventions: Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc; Device: Central line with CVP and continuous ScvO2 monitoring

• Registration Number: NCT00535821
• Lead Sponsor: Loma Linda University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2014-05
• Results First Submitted: 2014-05-22
• Results First Submitted QC: 2014-05-22
• Last Update Submitted: 2014-05-22
• Results First Posted: 2014-06-25
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiCHO	Esophageal Doppler monitoring - CardioQ, Deltex Inc	A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
EGDT	Central line with CVP and continuous ScvO2 monitoring	A 6-hour resuscitation protocol utilizing CVP/ScvO2

Primary Outcome Measures

Name	Time	Method
Mortality	hospital	In-hospital mortality

Trial Locations

Locations (4)

Loma Linda University; 🇺🇸 Loma Linda, California, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

VA Loma Linda Health Care System; 🇺🇸 Loma Linda, California, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States