Echo vs. EGDT in Severe Sepsis and Septic Shock

Study Overview
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Brief Summary
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Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use. Our study goals/objectives are as follows: To conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy (EGDT) protocol in patients with severe sepsis or septic shock. Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive EGDT. Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.

Official Title
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Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study

Conditions
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Severe Sepsis, Septic Shock

Intervention / Treatment
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* Other: Echo guided fluid resuscitation
* Other: EGDT fluid resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Suspected infection Two or more systemic inflammatory response syndrome (SIRS) criteria White blood cell count less than 4,000 per mm3, greater than 12,000 per mm3, or differential with greater than 10% immature forms Heart rate greater than 90 beats per minute Respiratory rate greater than 20 breaths per minute or paCO2 less than 32 mmHg Temperature less than 36°C or greater than 38°C Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following): Systolic blood pressure less than 90 mmHg despite an intravenous fluid challenge of at least 30ml/kg (a portion of this may be albumin equivalent) Blood lactate level at least 4 mmol/L. Intention to place an arterial catheter. Intention to place a central venous catheter. Exclusion criteria: Known pregnancy Requirement for immediate surgery Hypotension attributed to alternative cause Treating physician deems the patient is moribund Treating physician deems aggressive care is unsuitable Contraindication to central venous catheterization or arterial catheterization Advanced directives restricting implementation of the protocol Significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.) Children under the age of 18 will not be included in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Goal Directed Therapy (EGDT)<br>EGDT is currently standard of care in management of septic shock, so assignment to this treatment arm will confer no additional risk above that of standard of care. EGDT utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications. EGDT uses central venous catheter to assess central venous pressure and ScVO2. | Other: EGDT fluid resuscitation<br>* Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.<br>|
| Experimental: Echo Guided Fluid Resuscitation<br>The echo arm also utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications, all of which are interventions found in standard care. The central venous pressure will not be monitored in this arm. Instead, decisions for giving fluids will be directed by the results of Echocardiography. Echocardiography poses no known risk to the patient, and it is non-invasive. The only risk of echocardiography is that of misdiagnosis. | Other: Echo guided fluid resuscitation<br>* Patients will have their fluid resuscitation care guided by measurements obtained during an echo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms |  | up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient mortality in both treatment arms |  | Up to  7 days (Occurring during hospital stay). | 
| Time to lactate clearance in both treatment arms |  | Up to  7 days (Occurring during ICU hospital stay). | 
| Number of ICU-Free days |  | 28 days | 
| Daily and cumulative fluid balance in both treatment arms |  | Up to  7 days (Occurring during ICU hospital stay). | 
| Number of ventilator-free days |  | Up to  7 days (Occurring during ICU hospital stay). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, EGDT, Sepsis