- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354742
Echo vs. EGDT in Severe Sepsis and Septic Shock (ECHO RCT)
Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Utah
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Murray, Utah, United States, 84157
- Intermountain Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early Goal Directed Therapy (EGDT)
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.
|
Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.
|
Experimental: Echo Guided Fluid Resuscitation
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.
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Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
Time Frame: up to 72 hours
|
up to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inpatient mortality in both treatment arms
Time Frame: Up to ~7 days (Occurring during hospital stay).
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Up to ~7 days (Occurring during hospital stay).
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Time to lactate clearance in both treatment arms
Time Frame: Up to ~7 days (Occurring during ICU hospital stay).
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Up to ~7 days (Occurring during ICU hospital stay).
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Number of ICU-Free days
Time Frame: 28 days
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28 days
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Daily and cumulative fluid balance in both treatment arms
Time Frame: Up to ~7 days (Occurring during ICU hospital stay).
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Up to ~7 days (Occurring during ICU hospital stay).
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Number of ventilator-free days
Time Frame: Up to ~7 days (Occurring during ICU hospital stay).
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Up to ~7 days (Occurring during ICU hospital stay).
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1024925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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