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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2007

Last Updated Date

September 23, 2010

Start Date ^ICMJE

June 2007

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To show equivalency in hospital mortality outcome between MiCHO and EGDT [ Time Frame: In-hospital ]

Change History

Complete list of historical versions of study NCT00535821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Estimated Enrollment ^ICMJE

360

Completion Date

September 2010

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00535821

Other Study ID Numbers ^ICMJE

57121

Has Data Monitoring Committee

Responsible Party

H. Bryant Nguyen, MD, Principal Investigator, 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

Information Provided By

Loma Linda University

Verification Date

September 2010

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

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