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 (Responsible Party):
H. Bryant Nguyen, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00535821
First received: September 24, 2007
Last updated: May 22, 2014
Last verified: May 2014
  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:
  • Mortality [ Time Frame: hospital ] [ Designated as safety issue: No ]
    In-hospital mortality


Enrollment: 5
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
VA Loma Linda Health Care System
Loma Linda, California, United States, 92357
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, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT00535821     History of Changes
Other Study ID Numbers: 57121
Study First Received: September 24, 2007
Results First Received: May 22, 2014
Last Updated: May 22, 2014
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:
Shock
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014