Echocardiography in Septic Shock

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT02135796

Collaborator

(none)

700

Enrollment

Location

134

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Severe Sepsis	Other: Echocardiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ICU Echocardiography in Resuscitation of Sepsis and Septic Shock

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

at least 13 years of age

SEPSIS PATIENTS:

Sepsis patients must have

Suspected or confirmed infection

AND

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

SEPTIC SHOCK PATIENTS:

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

Suspected or confirmed infection

AND

Lactate > 2 mmol/L

AND

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.