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Echo vs. EGDT in Severe Sepsis and Septic Shock (ECHO RCT)

Primary Purpose

Severe Sepsis, Septic Shock

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echo guided fluid resuscitation
EGDT fluid resuscitation
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Echocardiography, EGDT, Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Early Goal Directed Therapy (EGDT)

Echo Guided Fluid Resuscitation

Arm Description

EGDT is currently standard of care in management of septic shock, so assignment to this treatment arm will confer no additional risk above that of standard of care. EGDT utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications. EGDT uses central venous catheter to assess central venous pressure and ScVO2.

The echo arm also utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications, all of which are interventions found in standard care. The central venous pressure will not be monitored in this arm. Instead, decisions for giving fluids will be directed by the results of Echocardiography. Echocardiography poses no known risk to the patient, and it is non-invasive. The only risk of echocardiography is that of misdiagnosis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inpatient mortality in both treatment arms
Time to lactate clearance in both treatment arms
Number of ICU-Free days
Daily and cumulative fluid balance in both treatment arms
Number of ventilator-free days

Full Information

First Posted
November 3, 2014
Last Updated
July 13, 2018
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02354742
Brief Title
Echo vs. EGDT in Severe Sepsis and Septic Shock
Acronym
ECHO RCT
Official Title
Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Echocardiography, EGDT, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Goal Directed Therapy (EGDT)
Arm Type
Active Comparator
Arm Description
EGDT is currently standard of care in management of septic shock, so assignment to this treatment arm will confer no additional risk above that of standard of care. EGDT utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications. EGDT uses central venous catheter to assess central venous pressure and ScVO2.
Arm Title
Echo Guided Fluid Resuscitation
Arm Type
Experimental
Arm Description
The echo arm also utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications, all of which are interventions found in standard care. The central venous pressure will not be monitored in this arm. Instead, decisions for giving fluids will be directed by the results of Echocardiography. Echocardiography poses no known risk to the patient, and it is non-invasive. The only risk of echocardiography is that of misdiagnosis.
Intervention Type
Other
Intervention Name(s)
Echo guided fluid resuscitation
Intervention Description
Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
Intervention Type
Other
Intervention Name(s)
EGDT fluid resuscitation
Intervention Description
Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.
Primary Outcome Measure Information:
Title
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
Time Frame
up to 72 hours
Secondary Outcome Measure Information:
Title
Inpatient mortality in both treatment arms
Time Frame
Up to ~7 days (Occurring during hospital stay).
Title
Time to lactate clearance in both treatment arms
Time Frame
Up to ~7 days (Occurring during ICU hospital stay).
Title
Number of ICU-Free days
Time Frame
28 days
Title
Daily and cumulative fluid balance in both treatment arms
Time Frame
Up to ~7 days (Occurring during ICU hospital stay).
Title
Number of ventilator-free days
Time Frame
Up to ~7 days (Occurring during ICU hospital stay).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lanspa, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30123511
Citation
Lanspa MJ, Burk RE, Wilson EL, Hirshberg EL, Grissom CK, Brown SM. Echocardiogram-guided resuscitation versus early goal-directed therapy in the treatment of septic shock: a randomized, controlled, feasibility trial. J Intensive Care. 2018 Aug 13;6:50. doi: 10.1186/s40560-018-0319-3. eCollection 2018.
Results Reference
derived

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Echo vs. EGDT in Severe Sepsis and Septic Shock

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