NEWS and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department

Completed

• Conditions: Triage Category 3 (Urgent)

• Registration Number: NCT02817581
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

To validate the NEWS and rapid lactate testing for early identification of high risk \[triage Category 3 (urgent)\] patients in the Emergency Department.

To compare qSOFA and SIRS criteria in patients in the Emergency Department.

Detailed Description

Background:

Sepsis is a potentially life-threatening complication of an infection. Early identification and early intervention are two main elements in improving patient care.

Objectives:

1. To validate the NEWS and rapid lactate testing for early identification of high risk \[triage Category 3 (urgent)\] patients in the Emergency Department.

2. To compare qSOFA and SIRS criteria in patients in the Emergency Department.

Study design:

This is a prospective, cohort study. Patients aged 18 or above presenting to the ED triaged as Category 3 (urgent) will be recruited. The required data for calculating NEWS will be collected at triage and triage lactate level will be measured by point-of-care analyzer.

Outcomes:

The primary outcome is referral for intensive care unit (ICU) admission during the patient's ED stay. The secondary outcomes are length of stay in hospital (LOS), hospital admission, admission to ICU, length of ICU-free admission (defined as days alive outside the ICU from admission to day 30) 30-day mortality and time to processes-of-care.

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Study Start: 2016-07
• Primary Completion: 2017-06-30
• Study Completion: 2017-12-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1255

Inclusion Criteria

• Aged 18 years or above who are triage category 3 in emergency department
• Presenting to emergency department between 9am and 4pm, Monday to Friday

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Exclusion Criteria

• Aged below 18 years
• Pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days after recruitment

Secondary Outcome Measures

Name	Time	Method
length of stay in hospital (LOS)	30 days after recruitment
hospital admission	30 days after recruitment
admission to ICU	30 days after recruitment
time to processes-of-care	24 hr after recruitment	time to lactate measured, time to antibiotics admission, time to blood culture obtained, time to fluid resuscitation, time to vasopressor administration from ED arrival
length of ICU-free admission	30 days after recruitment
referral for intensive care unit (ICU) admission	24 hr after recruitment

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, NT, Hong Kong