SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

NCT02170233 | Completed

• 1 other identifier: 1406014123
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Moore, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 23, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)