SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

Sepsis Clinical Trial

Official title:

SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170233
• Other study ID #: 1406014123
• Status: Completed
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Respirophasic carotid velocity (?Vpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.	Ultrasound Measure: Respirophasic carotid velocity (?Vpeak) 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	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
Secondary	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
Secondary	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