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

September 24, 2007
September 23, 2010
June 2007
September 2010   (final data collection date for primary outcome measure)
To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ]
Complete list of historical versions of study NCT00535821 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
360
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00535821
57121
No
H. Bryant Nguyen, MD, Principal Investigator, Loma Linda University
Loma Linda University
  • University of Massachusetts, Worcester
  • Wayne State University
  • VA Loma Linda Health Care System
Principal Investigator: H. Bryant Nguyen, MD Loma Linda University
Loma Linda University
September 2010

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