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Completed

NCT Number: NCT02354742

Echo vs. EGDT in Severe Sepsis and Septic Shock

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center

Murray, Utah, 84157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echo guided fluid resuscitation

Other

Patients will have their fluid resuscitation care guided by measurements obtained during an echo.

EGDT fluid resuscitation

Other

Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.

Primary outcomes

  1. Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms

    Time frame: up to 72 hours

Secondary outcomes

  1. Inpatient mortality in both treatment arms

    Time frame: Up to ~7 days (Occurring during hospital stay).

  2. Time to lactate clearance in both treatment arms

    Time frame: Up to ~7 days (Occurring during ICU hospital stay).

  3. Number of ICU-Free days

    Time frame: 28 days

  4. Daily and cumulative fluid balance in both treatment arms

    Time frame: Up to ~7 days (Occurring during ICU hospital stay).

  5. Number of ventilator-free days

    Time frame: Up to ~7 days (Occurring during ICU hospital stay).

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study

Acronym: ECHO RCT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2015
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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