Trial Outcomes & Findings for Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock (NCT NCT00535821)

NCT ID: NCT00535821

Last Updated: 2014-06-25

Results Overview

In-hospital mortality

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: hospital
• Results posted on: 2014-06-25

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MiCHO n=2 Participants 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 n=3 Participants 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 n=5 Participants Total of all reporting groups
Age, Continuous	81.5 years STANDARD_DEVIATION 10.5 • n=5 Participants	60.7 years STANDARD_DEVIATION 1.2 • n=7 Participants	69.0 years STANDARD_DEVIATION 6.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
SBP < 90 or Lactate >= 4 mmol/L	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: hospital

In-hospital mortality

Outcome measures

Measure	MiCHO n=2 Participants 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 n=3 Participants 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
Mortality	0 participants	0 participants

Adverse Events

MiCHO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EGDT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

H. Bryant Nguyen

Loma Linda University

Phone: 909-558-4000

Email: hbnguyen@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place