Echo vs. EGDT in Severe Sepsis and Septic Shock

Completed · Not applicable

Conditions studied: Severe Sepsis, Septic Shock

In brief

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.

Key facts

Study ID

NCT02354742

Run by

Intermountain Health Care, Inc.

People needed

80

Starts

2014-12-01

Expected to finish

2017-10-01

Last updated by the study team

2018-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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