Septic Shock, Severe Sepsis
Conditions
Keywords
Emergency Department, Hemodynamic Optimization, Esophageal Doppler monitoring, Early Goal-Directed Therapy
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.
Interventions
DEVICEEsophageal Doppler monitoring - CardioQ, Deltex Inc
6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
DEVICECentral line with CVP and continuous ScvO2 monitoring
6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
Sponsors
University of Massachusetts, Worcester
Wayne State University
VA Loma Linda Health Care System
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | hospital | In-hospital mortality |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | MiCHO | EGDT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Continuous | 81.5 years STANDARD_DEVIATION 10.5 | 60.7 years STANDARD_DEVIATION 1.2 | 69.0 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| SBP < 90 or Lactate >= 4 mmol/L | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Mortality
In-hospital mortality
Time frame: hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiCHO | Mortality | 0 participants |
| EGDT | Mortality | 0 participants |