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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MiCHO

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

Group Type EXPERIMENTAL

Esophageal Doppler monitoring - CardioQ, Deltex Inc

Intervention Type DEVICE

6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM

EGDT

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Group Type ACTIVE_COMPARATOR

Central line with CVP and continuous ScvO2 monitoring

Intervention Type DEVICE

6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

Interventions

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Esophageal Doppler monitoring - CardioQ, Deltex Inc

6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No