Clinical trial NCT02354742: Echo vs. EGDT in Severe Sepsis and Septic Shock
Official title: Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Septic Shock
Keywords: Echocardiography
EGDT
Sepsis
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
timeFrame: up to 72 hours
Secondary outcomes:
measure: Inpatient mortality in both treatment arms
timeFrame: Up to ~7 days (Occurring during hospital stay).
measure: Time to lactate clearance in both treatment arms
timeFrame: Up to ~7 days (Occurring during ICU hospital stay).
measure: Number of ICU-Free days
timeFrame: 28 days
measure: Daily and cumulative fluid balance in both treatment arms
timeFrame: Up to ~7 days (Occurring during ICU hospital stay).
measure: Number of ventilator-free days
timeFrame: Up to ~7 days (Occurring during ICU hospital stay).
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Michael Lanspa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.