Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
700 participants
OBSERVATIONAL
2008-10-31
2019-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Echocardiography
Interventions
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Echocardiography
Eligibility Criteria
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Inclusion Criteria
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
13 Years
ALL
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
Responsible Party
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Principal Investigators
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Michael Lanspa, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Health Care, Inc.
Locations
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Intermountain Medical Center
Murray, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Lanspa, MD
Role: primary
Other Identifiers
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1009957
Identifier Type: -
Identifier Source: org_study_id
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