Septic Shock, Severe Sepsis
Conditions
Keywords
Echocardiography, EGDT, Sepsis
Brief summary
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: 1. 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. 2. 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. 3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.
Interventions
OTHEREcho guided fluid resuscitation
Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
OTHEREGDT fluid resuscitation
Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.
Sponsors
Intermountain Health Care, Inc.
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms | up to 72 hours |
Secondary
| Measure | 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). |
Countries
United States
Outcome results
None listed