Echo vs. EGDT in Severe Sepsis and Septic Shock (NCT02354742) | Clinical Trial Compass
CompletedNot Applicable
Echo vs. EGDT in Severe Sepsis and Septic Shock
United States80 participantsStarted 2014-12
Plain-language 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.
Our study goals/objectives are as follows:
1. 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.
2. 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.
3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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.
Exclusion criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms