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

Loma Linda University (LLU)

Status and phase: Terminated; Phase 4

Conditions: Severe Sepsis; Septic Shock

Treatments: Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc; Device: Central line with CVP and continuous ScvO2 monitoring

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00535821

57121

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

MiCHO

Experimental group

Description:

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

Treatment:

Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc

EGDT

Active Comparator group

Description:

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Treatment:

Device: Central line with CVP and continuous ScvO2 monitoring