Severe SepsisECHO RCTNCT02354742
Echo vs. EGDT in Severe Sepsis and Septic Shock
A study testing Echo guided fluid resuscitation and EGDT fluid resuscitation in people with Severe Sepsis and Septic Shock, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Echo guided fluid resuscitation and EGDT fluid resuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Suspected infection
- Two or more systemic inflammatory response syndrome (SIRS) criteria
- White blood cell count less than 4,000 per mm3, greater than 12,000 per mm3, or differential with greater than 10% immature forms
- Heart rate greater than 90 beats per minute
- Respiratory rate greater than 20 breaths per minute or paCO2 less than 32 mmHg
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- Temperature less than 36°C or greater than 38°C
- Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following):
- Systolic blood pressure less than 90 mmHg despite an intravenous fluid challenge of at least 30ml/kg (a portion of this may be albumin equivalent)
- Blood lactate level at least 4 mmol/L.
- Intention to place an arterial catheter.
- Intention to place a central venous catheter.
Who cannot join
- Known pregnancy
- Requirement for immediate surgery
- Hypotension attributed to alternative cause
- Treating physician deems the patient is moribund
- Treating physician deems aggressive care is unsuitable
- Contraindication to central venous catheterization or arterial catheterization
Show all 9Show fewer
- Advanced directives restricting implementation of the protocol
- Significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.)
- Children under the age of 18 will not be included in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use.
Our study goals/objectives are as follows:
- To conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy (EGDT) protocol in patients with severe sepsis or septic shock.
- Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive EGDT.
- Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- Echo guided fluid resuscitation, EGDT fluid resuscitation
- Keywords
- Echocardiography, EGDT, Sepsis
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo guided fluid resuscitationOther
Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
EGDT fluid resuscitationOther
Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Early Goal Directed Therapy (EGDT) | Active comparator | EGDT is currently standard of care in management of septic shock, so assignment to this treatment arm will confer no additional risk above that of standard of care. EGDT utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications. EGDT uses central venous catheter to assess central venous pressure and ScVO2. Receives: Other: EGDT fluid resuscitation |
| Echo Guided Fluid Resuscitation | Experimental | The echo arm also utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications, all of which are interventions found in standard care. The central venous pressure will not be monitored in this arm. Instead, decisions for giving fluids will be directed by the results of Echocardiography. Echocardiography poses no known risk to the patient, and it is non-invasive. The only risk of echocardiography is that of misdiagnosis. Receives: Other: Echo guided fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
Measured: up to 72 hours
Secondary outcomes (5)
Inpatient mortality in both treatment arms
Measured: Up to ~7 days (Occurring during hospital stay).
Time to lactate clearance in both treatment arms
Measured: Up to ~7 days (Occurring during ICU hospital stay).
Number of ICU-Free days
Measured: 28 days
Daily and cumulative fluid balance in both treatment arms
Measured: Up to ~7 days (Occurring during ICU hospital stay).
Number of ventilator-free days
Measured: Up to ~7 days (Occurring during ICU hospital stay).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT02354742
- Sponsor's protocol ID
- 1024925
- Acronym
- ECHO RCT
- Status last verified
- Jul 2018
- First submitted
- 3 Nov 2014
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lanspa MJ, Burk RE, Wilson EL, Hirshberg EL, Grissom CK, Brown SM. Echocardiogram-guided resuscitation versus early goal-directed therapy in the treatment of septic shock: a randomized, controlled, feasibility trial. J Intensive Care. 2018 Aug 13;6:50. doi: 10.1186/s40560-018-0319-3. eCollection 2018.
PubMed 30123511
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
- ClinicalTrials.gov ID
- NCT02354742
- Acronym / sponsor ID
- ECHO RCT / 1024925
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Echocardiography, EGDT, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 3 Feb 2015 (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.
Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use.
Our study goals/objectives are as follows:
- To conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy (EGDT) protocol in patients with severe sepsis or septic shock.
- Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive EGDT.
- Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Goal Directed Therapy (EGDT) | Active comparator | Other: EGDT fluid resuscitationEGDT is currently standard of care in management of septic shock, so assignment to this treatment arm will confer no additional risk above that of standard of care. EGDT utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications. EGDT uses central venous catheter to assess central venous pressure and ScVO2. |
| Echo Guided Fluid Resuscitation | Experimental | Other: Echo guided fluid resuscitationThe echo arm also utilizes placement of a central venous catheter, an arterial catheter, and administration of intravenous fluid and vasoactive medications, all of which are interventions found in standard care. The central venous pressure will not be monitored in this arm. Instead, decisions for giving fluids will be directed by the results of Echocardiography. Echocardiography poses no known risk to the patient, and it is non-invasive. The only risk of echocardiography is that of misdiagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years of age
- Suspected infection
- Two or more systemic inflammatory response syndrome (SIRS) criteria
- Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following):
- Intention to place an arterial catheter.
Key exclusion criteria (9 listed)
- Known pregnancy
- Requirement for immediate surgery
- Hypotension attributed to alternative cause
- Treating physician deems the patient is moribund
- Treating physician deems aggressive care is unsuitable
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 |
|---|---|---|
| Echo guided fluid resuscitationPatients will have their fluid resuscitation care guided by measurements obtained during an echo. | Other | Echo Guided Fluid Resuscitation |
| EGDT fluid resuscitationPatients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care. | Other | Early Goal Directed Therapy (EGDT) |
Primary outcome
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
Time frame: up to 72 hours
5 secondary outcomes
Inpatient mortality in both treatment arms
Time frame: Up to ~7 days (Occurring during hospital stay).
Time to lactate clearance in both treatment arms
Time frame: Up to ~7 days (Occurring during ICU hospital stay).
Number of ICU-Free days
Time frame: 28 days
Daily and cumulative fluid balance in both treatment arms
Time frame: Up to ~7 days (Occurring during ICU hospital stay).
Number of ventilator-free days
Time frame: Up to ~7 days (Occurring during ICU hospital stay).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Derived from this study: PubMed 30123511Lanspa MJ, Burk RE, Wilson EL, Hirshberg EL, Grissom CK, Brown SM. Echocardiogram-guided resuscitation versus early goal-directed therapy in the treatment of septic shock: a randomized, controlled, feasibility trial. J Intensive Care. 2018 Aug 13;6:50. doi: 10.1186/s40560-018-0319-3. eCollection 2018.
- 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?
A study testing Echo guided fluid resuscitation and EGDT fluid resuscitation in people with Severe Sepsis and Septic Shock, 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354742, which also lists 1 linked publication.
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 16 Jul 2018.