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

This study has been terminated.
(slow enrollement unavailable technology)
Sponsor:
Collaborators:
University of Massachusetts, Worcester
Wayne State University
VA Loma Linda Health Care System
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00535821
First received: September 24, 2007
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Severe Sepsis
Septic Shock
Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc
Device: Central line with CVP and continuous ScvO2 monitoring
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of fluids, vasopressor, transfusion, and inotrope usage in MiCHO vs. EGDT. Effects of MiCHO vs. EGDT on hemodynamic variables during the first 6 hours of septic shock management. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: June 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MiCHO
A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc
6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
Active Comparator: EGDT
A 6-hour resuscitation protocol utilizing CVP/ScvO2
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535821

Locations
United States, California
VA Loma Linda Health Care System
Loma Linda, California, United States, 92357
Loma Linda University
Loma Linda, California, United States, 92354
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Loma Linda University
University of Massachusetts, Worcester
Wayne State University
VA Loma Linda Health Care System
Investigators
Principal Investigator: H. Bryant Nguyen, MD Loma Linda University
  More Information

Publications:
Responsible Party: H. Bryant Nguyen, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT00535821     History of Changes
Other Study ID Numbers: 57121
Study First Received: September 24, 2007
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Emergency Department
Hemodynamic Optimization
Esophageal Doppler monitoring
Early Goal-Directed Therapy

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014