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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MiCHO EGDT
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title MiCHO EGDT Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
81.5  (10.5) 60.7  (1.2) 69.0  (6.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
3
 100.0%
3
  60.0%
>=65 years
2
 100.0%
0
   0.0%
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
1
  33.3%
1
  20.0%
Male
2
 100.0%
2
  66.7%
4
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
SBP < 90 or Lactate >= 4 mmol/L  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Mortality
Hide Description In-hospital mortality
Time Frame hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MiCHO EGDT
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2 3
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MiCHO EGDT
Hide Arm/Group Description

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

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

All-Cause Mortality
MiCHO EGDT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
MiCHO EGDT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MiCHO EGDT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: H. Bryant Nguyen
Organization: Loma Linda University
Phone: 909-558-4000 ext 44023
EMail: hbnguyen@llu.edu
Layout table for additonal information
Responsible Party: H. Bryant Nguyen, Loma Linda University
ClinicalTrials.gov Identifier: NCT00535821    
Other Study ID Numbers: 57121
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: May 22, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014