Echocardiography in Septic Shock

ICU Echocardiography in Resuscitation of Sepsis and Septic Shock

BACKGROUND: Echocardiography can provide evaluation of right or left ventricular dysfunction and volume status during resuscitation of patients with sepsis and septic shock and guide intravenous vasopressor and fluid therapy. While there are numerous echocardiographic studies regarding cardiac function and volume status in patients with established shock, there are none that describe these during the early resuscitation of septic shock.

The study objective is to correlate echocardiographic findings with clinical parameters and net fluid balance measured during the early resuscitation of critically ill patients with sepsis and septic shock.

Aim 1) correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation

Aim 2) correlate cardiac function and fluid status with clinical outcomes

Aim 3) evaluate the change in cardiac function over time in patients with sepsis and septic shock

Aim 4) evaluate long term clinical outcomes for patients with sepsis and septic shock.

Study Overview

• Status: Unknown
• Conditions: Septic Shock; Severe Sepsis
• Intervention / Treatment: Other: Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Kimberly Rhodes; Phone Number: 801-507-4791; Email: kimberly.rhodes@imail.org
• Study Contact Backup: Name: Michael Lanspa, MD; Phone Number: (801) 507-6554; Email: Michael.Lanspa@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an Intensive Care Unit (ICU) with an initial diagnosis of severe sepsis or septic shock.

Description

Inclusion Criteria:

- at least 13 years of age

SEPSIS PATIENTS:

Sepsis patients must have

1. Suspected or confirmed infection

   AND

2. Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, Septic shock patients must have

1. Suspected or confirmed infection

   AND

2. Lactate > 2 mmol/L

   AND

3. Receiving vasopressors

   • Enrollment of patients should occur within 8 hours of meeting criteria for severe sepsis or septic shock if it is required that a research only TTE be performed in the 0-6 hours after ICU admission. If a clinical TTE is performed in this timeframe, patients may be enrolled up to 24 hours after ICU admission.

Exclusion Criteria:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis/Septic Shock; Individuals who are admitted to the Intensive Care Unit (ICU) with an infection called Sepsis or Septic Shock. This group will receive transthoracic echocardiography as part of the study.	Other: Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate echo findings and markers of resuscitation	Correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation. Specifically, cardiac markers will be analyzed in relation to cardiac function, including ejection fraction, strain, and diastolic function, and correlate these with several clinical parameters, including receipt of fluid, vasopressors, mechanical ventilation, and septic cardiomyopathy	Within 12 hours of Intensive Care Unit admission

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (ESTIMATE): May 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ICU; Septic Shock; Severe Sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 1009957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO