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Echocardiography in Septic Shock

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ClinicalTrials.gov Identifier: NCT02135796
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Septic Shock Severe Sepsis Other: Echocardiography

Study Type : Observational
Estimated Enrollment : 172 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ICU Echocardiography in Resuscitation of Sepsis and Septic Shock
Study Start Date : October 2008
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

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 tansthoracic echocardiography as part of the study.
Other: Echocardiography



Primary Outcome Measures :
  1. Correlate echo findings and markers of resuscitation [ Time Frame: 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



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135796


Contacts
Contact: Kimberly Rhodes 801-507-4791 kimberly.rhodes@imail.org
Contact: Michael Lanspa, MD (801) 507-6554 Michael.Lanspa@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Michael Lanspa, MD    801-507-6556      
Principal Investigator: Michael Lanspa, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Michael Lanspa, MD Intermountain Health Care, Inc.

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02135796     History of Changes
Other Study ID Numbers: 1009957
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Intermountain Health Care, Inc.:
Septic Shock
Severe Sepsis
ICU

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes