SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

Completed

• Conditions: Sepsis

• Registration Number: NCT02170233
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Study Start: 2014-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States