Clinical trial NCT02170233: SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography
Official title: SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 severe sepsis or septic shock during their emergency department visit. A number of healthy patients will also be enrolled to act as controls for this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Secondary outcomes:
measure: Fluid volume measurement as measured by ultrasound
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Early (E') septal left ventricular filling velocity as measured by ultrasound
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Late (A') septal left ventricular filling velocity as measured by ultrasound
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
measure: Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
timeFrame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Chris Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: