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Echo vs. EGDT in Severe Sepsis and Septic Shock

NCT02354742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-07-16

No results posted yet for this study

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.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

OTHER

Echo guided fluid resuscitation

Patients will have their fluid resuscitation care guided by measurements obtained during an echo.

OTHER

EGDT fluid resuscitation

Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Michael Lanspa, MD · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-05-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02354742 on ClinicalTrials.gov