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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Goal Directed Therapy (EGDT) | Active Comparator | 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. |
|
| Echo Guided Fluid Resuscitation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echo guided fluid resuscitation | Other | Patients will have their fluid resuscitation care guided by measurements obtained during an echo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms | up to 72 hours |
| 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). |
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Inclusion Criteria:
At least 18 years of age
Suspected infection
Two or more systemic inflammatory response syndrome (SIRS) criteria
Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following):
Intention to place an arterial catheter.
Intention to place a central venous catheter.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lanspa, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30123511 | Derived | Lanspa MJ, Burk RE, Wilson EL, Hirshberg EL, Grissom CK, Brown SM. Echocardiogram-guided resuscitation versus early goal-directed therapy in the treatment of septic shock: a randomized, controlled, feasibility trial. J Intensive Care. 2018 Aug 13;6:50. doi: 10.1186/s40560-018-0319-3. eCollection 2018. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| EGDT fluid resuscitation | Other | Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care. |
|
| 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). |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |