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

Validation of National Early Warning Score (NEWS) and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Triage Category 3 (Urgent)

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 Type: Observational
• Enrollment (Actual): 1255

Contacts and Locations

Study Locations

• Hong Kong
  • NT
    • Sha Tin, NT, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 or above who are triage category 3 presenting to Emergency Department

Description

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

Exclusion Criteria:

• Aged below 18 years
• Pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day mortality	30 days after recruitment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Emergency Department; Lactate; National Early Warning Score (NEWS)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: CRE- 2016.236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES