Septic ShockNCT02135796
Echocardiography in Septic Shock
An observational study of Septic Shock and Severe Sepsis, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Septic Shock, Severe Sepsis
- What is being tested?
- Echocardiography
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to an Intensive Care Unit (ICU) with an initial diagnosis of severe sepsis or septic shock.
Who may be able to join
- 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)
Show all 15Show fewer
- OR
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84157
Michael Lanspa, MD, 801-507-6556
Michael Lanspa, MD
About this study
Official title: ICU Echocardiography in Resuscitation of Sepsis and Septic Shock
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.
Read more
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
- Being tested
- Echocardiography
- Keywords
- Septic Shock, Severe Sepsis, ICU
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 12 hours of Intensive Care Unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startOct 2008
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lanspa, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135796
- Sponsor's protocol ID
- 1009957
- Status last verified
- Jun 2019
- First submitted
- 8 May 2014
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Echocardiography in Resuscitation of Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT02135796
- Acronym / sponsor ID
- 1009957
- Conditions
- Septic Shock, Severe Sepsis
- Keywords
- Septic Shock, Severe Sepsis, ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis/Septic Shock | – | Other: EchocardiographyIndividuals 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to an Intensive Care Unit (ICU) with an initial diagnosis of severe sepsis or septic shock.
Key inclusion criteria (15 listed)
- at least 13 years of age
- 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)
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography | Other | Sepsis/Septic Shock |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lanspa, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Severe Sepsis, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Rhodes (801-507-4791, kimberly.rhodes@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate echo findings and markers of resuscitation (time frame: Within 12 hours of Intensive Care Unit admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.