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
Results First Received: May 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Severe Sepsis
Septic Shock
Interventions: Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc
Device: Central line with CVP and continuous ScvO2 monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MiCHO

A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)

Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM

EGDT

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring


Participant Flow:   Overall Study
    MiCHO     EGDT  
STARTED     2     3  
COMPLETED     2     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MiCHO

A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)

Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM

EGDT

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

Total Total of all reporting groups

Baseline Measures
    MiCHO     EGDT     Total  
Number of Participants  
[units: participants]
  2     3     5  
Age  
[units: years]
Mean ± Standard Deviation
  81.5  ± 10.5     60.7  ± 1.2     69.0  ± 6.1  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     3     3  
>=65 years     2     0     2  
Gender  
[units: participants]
     
Female     0     1     1  
Male     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     2     3     5  
SBP < 90 or Lactate >= 4 mmol/L  
[units: participants]
  2     3     5  



  Outcome Measures

1.  Primary:   Mortality   [ Time Frame: hospital ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: H. Bryant Nguyen
Organization: Loma Linda University
phone: 909-558-4000 ext 44023
e-mail: hbnguyen@llu.edu


Publications:

Responsible Party: H. Bryant Nguyen, 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