Echocardiography in Septic Shock

• Conditions: Septic Shock; Severe Sepsis
• Interventions: Other: Echocardiography

• Registration Number: NCT02135796
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-13
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis/Septic Shock	Echocardiography	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.

Primary Outcome Measures

Name	Time	Method
Correlate echo findings and markers of resuscitation	Within 12 hours of Intensive Care Unit admission	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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States