Echo vs. EGDT in Severe Sepsis and Septic Shock

Septic Shock Clinical Trial

— ECHO RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354742
• Other study ID #: 1024925
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2017

Study information

• Verified date: July 2018
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Intervention

Other:
• Echo guided fluid resuscitation
Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
• EGDT fluid resuscitation
Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms		up to 72 hours
Secondary	Inpatient mortality in both treatment arms		Up to ~7 days (Occurring during hospital stay).
Secondary	Time to lactate clearance in both treatment arms		Up to ~7 days (Occurring during ICU hospital stay).
Secondary	Number of ICU-Free days		28 days
Secondary	Daily and cumulative fluid balance in both treatment arms		Up to ~7 days (Occurring during ICU hospital stay).
Secondary	Number of ventilator-free days		Up to ~7 days (Occurring during ICU hospital stay).