Recruiting

Observational Study

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT02135796

Conditions

Septic Shock

Severe Sepsis

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Echocardiography

Study Details

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

Study ID

NCT02135796

Start date

Oct, 2008

Status verified date

Jun, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Echocardiography

Primary outcome measure

  • Correlate echo findings and markers of resuscitation [ Time Frame: Within 12 hours of Intensive Care Unit admission ]

Central Contacts and Locations

Central contacts

Kimberly Rhodes

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

Michael Lanspa, MD

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

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Michael Lanspa, MD

801-507-6556

Principal Investigator:

Michael Lanspa, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Jun 13, 2019

Last verified

Jun, 2019

Keywords

  • Septic Shock
  • Severe Sepsis
  • ICU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2019-06-13.