Sepsis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid | 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
| Measure | Time frame | Description |
|---|---|---|
| Early (E') septal left ventricular filling velocity as measured by ultrasound | 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. |
| Late (A') septal left ventricular filling velocity as measured by ultrasound | 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. |
| Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness. | 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. |
| Fluid volume measurement as measured by ultrasound | 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. |
| Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound. | 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. |
| Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound. | 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. |
| Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound. | 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. |
Countries
United States
Outcome results
None listed