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

Intermountain Health Care, Inc.1 site in 1 country80 target enrollmentDecember 2014

ConditionsSevere Sepsis Septic Shock

Overview

Phase: N/A
Intervention: Not specified
Conditions: Severe Sepsis
Sponsor: Intermountain Health Care, Inc.
Enrollment: 80
Locations: 1
Primary Endpoint: Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

October 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Intermountain Health Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms

Time Frame: up to 72 hours

Secondary Outcomes

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)
Number of ventilator-free days(Up to ~7 days (Occurring during ICU hospital stay).)
Daily and cumulative fluid balance in both treatment arms(Up to ~7 days (Occurring during ICU hospital stay).)