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Completed

NCT Number: NCT02817581

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, NT, Hong Kong

About this study

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:

  • 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days after recruitment

Secondary outcomes

  1. referral for intensive care unit (ICU) admission

    Time frame: 24 hr after recruitment

  2. length of stay in hospital (LOS)

    Time frame: 30 days after recruitment

  3. hospital admission

    Time frame: 30 days after recruitment

  4. admission to ICU

    Time frame: 30 days after recruitment

  5. length of ICU-free admission

    Time frame: 30 days after recruitment

  6. time to processes-of-care

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2016
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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