Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department

Recruiting

• Conditions: Sepsis

• Registration Number: NCT05544903
• Lead Sponsor: Northwell Health

Brief Summary

The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Emergency department patient
• 18+ years old
• Systolic blood pressure less than 100mmHg
• Respiratory rate greater than 22 breaths per minutes
• Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius
• Heart rate greater than 90 beats per minute

Exclusion Criteria

• Already intubated prior to emergency department arrival
• Ventilator-dependent
• Patients transferred from another hospital
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rapid response team activation	24 hours	This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.
Mortality	24 hours	This study will ascertain whether the patient died within 24 hours of ED arrival.
ICU admission	24 hours	This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States