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

Primary Purpose

Severe Sepsis, Septic Shock

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esophageal Doppler monitoring - CardioQ, Deltex Inc
Central line with CVP and continuous ScvO2 monitoring
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Emergency Department, Hemodynamic Optimization, Esophageal Doppler monitoring, Early Goal-Directed Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University
  • VA Loma Linda Health Care System
  • University of Massachusetts
  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiCHO

EGDT

Arm Description

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

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Outcomes

Primary Outcome Measures

Mortality
In-hospital mortality

Secondary Outcome Measures

Full Information

First Posted
September 24, 2007
Last Updated
May 22, 2014
Sponsor
Loma Linda University
Collaborators
University of Massachusetts, Worcester, Wayne State University, VA Loma Linda Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00535821
Brief Title
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
Acronym
MiCHO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
slow enrollement unavailable technology
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
University of Massachusetts, Worcester, Wayne State University, VA Loma Linda Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Emergency Department, Hemodynamic Optimization, Esophageal Doppler monitoring, Early Goal-Directed Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiCHO
Arm Type
Experimental
Arm Description
A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Arm Title
EGDT
Arm Type
Active Comparator
Arm Description
A 6-hour resuscitation protocol utilizing CVP/ScvO2
Intervention Type
Device
Intervention Name(s)
Esophageal Doppler monitoring - CardioQ, Deltex Inc
Intervention Description
6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
Intervention Type
Device
Intervention Name(s)
Central line with CVP and continuous ScvO2 monitoring
Intervention Description
6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
Primary Outcome Measure Information:
Title
Mortality
Description
In-hospital mortality
Time Frame
hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Bryant Nguyen, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
VA Loma Linda Health Care System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11794169
Citation
Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
Results Reference
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PubMed Identifier
15242867
Citation
McKendry M, McGloin H, Saberi D, Caudwell L, Brady AR, Singer M. Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004 Jul 31;329(7460):258. doi: 10.1136/bmj.38156.767118.7C. Epub 2004 Jul 8. Erratum In: BMJ. 2004 Aug 21;329(7463):438.
Results Reference
background
PubMed Identifier
17313691
Citation
Chytra I, Pradl R, Bosman R, Pelnar P, Kasal E, Zidkova A. Esophageal Doppler-guided fluid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care. 2007;11(1):R24. doi: 10.1186/cc5703.
Results Reference
background
PubMed Identifier
16137384
Citation
Gunn SR, Fink MP, Wallace B. Equipment review: the success of early goal-directed therapy for septic shock prompts evaluation of current approaches for monitoring the adequacy of resuscitation. Crit Care. 2005 Aug;9(4):349-59. doi: 10.1186/cc3725. Epub 2005 May 27.
Results Reference
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Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock

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