Clinical trial NCT02817581: NEWS and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department
Official title: Validation of National Early Warning Score (NEWS) and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Triage Category 3 (Urgent)
Keywords: National Early Warning Score (NEWS)
Lactate
Emergency Department
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 1255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 or above who are triage category 3 presenting to Emergency Department

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after recruitment
Secondary outcomes:
measure: referral for intensive care unit (ICU) admission
timeFrame: 24 hr after recruitment
measure: length of stay in hospital (LOS)
timeFrame: 30 days after recruitment
measure: hospital admission
timeFrame: 30 days after recruitment
measure: admission to ICU
timeFrame: 30 days after recruitment
measure: length of ICU-free admission
timeFrame: 30 days after recruitment
measure: time to processes-of-care
timeFrame: 24 hr after recruitment
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: NT
Study officials:
affiliation: Chinese University of Hong Kong
name: Colin A Graham, MD
role: PRINCIPAL_INVESTIGATOR
References: