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

NCT00535821 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-06-25

Study results available
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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

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

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Wayne State University

    collaborator OTHER

  • VA Loma Linda Health Care System

    collaborator FED

  • Loma Linda University

    lead OTHER

Principal Investigators

  • H. Bryant Nguyen, MD · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00535821 on ClinicalTrials.gov