SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

Yale University

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT02170233

1406014123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

Sepsis

Description:

This group will contain patients meeting criteria for sepsis for enrollment in the study (target population).

Normals

Description:

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.