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.

Study Overview

• Status: Completed
• Conditions: Sepsis

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sepsis; This group will contain patients meeting criteria for sepsis for enrollment in the study (target population).
Normals; This group will be healthy patients who will have data points recorded for controls for the study to assess the reliability of these measures on healthy patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid	Ultrasound Measurement: Carotid corrected flow time 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid volume measurement as measured by ultrasound	Ultrasound Measurement: IVC diameter 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
Early (E') septal left ventricular filling velocity as measured by ultrasound	Ultrasound Measurement: Early (E') septal left ventricular filling velocity by tissue Doppler 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
Late (A') septal left ventricular filling velocity as measured by ultrasound	Ultrasound Measure: Late (A') septal left ventricular filling velocity by Tissue Doppler 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
Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.	Ultrasound Measure: Respirophasic carotid velocity (ΔVpeak) 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
Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.	Ultrasound Measurement: Early (E) mitral inflow velocity 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
Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.	Ultrasound Measurement: Late (A) mitral inflow velocity 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
Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.	Ultrasound Measurement: Carotid velocity-time integral 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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Chris Moore, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 1406014123