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

Triage Category 3 (Urgent) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817581
• Other study ID #: CRE- 2016.236
• Status: Completed
• Start date: July 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: August 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1255
• Est. completion date: December 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Triage Category 3 (Urgent)

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin	NT

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality		30 days after recruitment
Secondary	referral for intensive care unit (ICU) admission		24 hr after recruitment
Secondary	length of stay in hospital (LOS)		30 days after recruitment
Secondary	hospital admission		30 days after recruitment
Secondary	admission to ICU		30 days after recruitment
Secondary	length of ICU-free admission		30 days after recruitment
Secondary	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