Echocardiography in Septic Shock

NCT02135796 | Unknown

• 1 other identifier: 1009957
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Severe Sepsis

Keywords

Septic Shock; Severe Sepsis; ICU

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Echocardiography OTHER

Sepsis/Septic Shock

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Michael Lanspa, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Rhodes

CONTACT

801-507-4791; kimberly.rhodes@imail.org

Michael Lanspa, MD

CONTACT

(801) 507-6554; Michael.Lanspa@imail.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: October 1, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)