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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00535821
Recruitment Status : Terminated (slow enrollement unavailable technology)
First Posted : September 26, 2007
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
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

Tracking Information
First Submitted Date  ICMJE September 24, 2007
First Posted Date  ICMJE September 26, 2007
Results First Submitted Date  ICMJE May 22, 2014
Results First Posted Date  ICMJE June 25, 2014
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
Mortality [ Time Frame: hospital ]
In-hospital mortality
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Severe Sepsis
  • Septic Shock
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MiCHO
    A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
    Intervention: Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc
  • Active Comparator: EGDT
    A 6-hour resuscitation protocol utilizing CVP/ScvO2
    Intervention: Device: Central line with CVP and continuous ScvO2 monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 22, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2007)
360
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535821
Other Study ID Numbers  ICMJE 57121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Bryant Nguyen, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE
  • University of Massachusetts, Worcester
  • Wayne State University
  • VA Loma Linda Health Care System
Investigators  ICMJE
Principal Investigator: H. Bryant Nguyen, MD Loma Linda University
PRS Account Loma Linda University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP