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Completed

NCT Number: NCT02170233

SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

After each 1 Liter fluid challenge of IV fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients age greater than 18 years who meet criteria of sepsis. Septic shock will be defined as those patients with severe sepsis and persistent hypotension (<90mmHg systolic blood pressure) despite a fluid challenge of at least 20cc/kg
  • Patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial US is performed
  • A number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. These patients will only have one ultrasound performed for each of the desired study measures.

Exclusion criteria

  • Patients unable to provide consent such as non-English speaking patients or patient/health care proxy unable to give consent
  • History of significant trauma
  • Incarcerated patients
  • Failure to complete fluid challenge
  • Pericardial disease or heart transplant. Patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (Ejection Fraction <40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately

Treatment and study plan

Primary outcomes

  1. Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    Carotid corrected flow time in relation to cardiac output to assess fluid responsiveness.

Secondary outcomes

  1. Fluid volume measurement as measured by ultrasound

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    IVC diameter in relation to cardiac output to assess fluid responsiveness.

  2. Early (E') septal left ventricular filling velocity as measured by ultrasound

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    Early (E') septal left ventricular filling velocity by tissue Doppler in relation to cardiac output to assess fluid responsiveness.

  3. Late (A') septal left ventricular filling velocity as measured by ultrasound

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measure:

    Late (A') septal left ventricular filling velocity by Tissue Doppler in relation to cardiac output to assess fluid responsiveness.

  4. Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measure:

    Respirophasic carotid velocity (ΔVpeak) in relation to cardiac output to assess fluid responsiveness.

  5. Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness.

  6. Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness.

  7. Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.

    Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours

    Ultrasound Measurement:

    Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Jan 13, 2020

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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