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Echocardiography in Septic Shock

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ClinicalTrials.gov Identifier: NCT02135796
Recruitment Status : Unknown
Verified June 2019 by Intermountain Health Care, Inc..
Recruitment status was:  Recruiting
First Posted : May 12, 2014
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Tracking Information
First Submitted Date May 8, 2014
First Posted Date May 12, 2014
Last Update Posted Date June 13, 2019
Study Start Date October 2008
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2017)
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
Original Primary Outcome Measures
 (submitted: May 8, 2014)
Correlate echo findings and CVP & ScvO2 [ Time Frame: Within 12 hours of Intensive Care Unit admission ]
Correlate echocardiographic findings of right ventricular (RV) systolic function and dilation, left ventricular (LV) systolic function and dilation, and left ventricular diastolic function with CVP and ScvO2 in the early hours of resuscitation in patients with severe sepsis and septic shock.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Echocardiography in Septic Shock
Official Title ICU Echocardiography in Resuscitation of Sepsis and Septic Shock
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Septic Shock
  • Severe Sepsis
Intervention Other: Echocardiography
Study Groups/Cohorts 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.
Intervention: Other: Echocardiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 11, 2019)
700
Original Estimated Enrollment
 (submitted: May 8, 2014)
172
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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:

None.

Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02135796
Other Study ID Numbers 1009957
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Intermountain Health Care, Inc.
Study Sponsor Intermountain Health Care, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Michael Lanspa, MD Intermountain Health Care, Inc.
PRS Account Intermountain Health Care, Inc.
Verification Date June 2019