Triage Category 3 (Urgent)NCT02817581
NEWS and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department
An observational study of Triage Category 3 (Urgent), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triage Category 3 (Urgent)
- How many people
- 1,255 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2016to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 or above who are triage category 3 presenting to Emergency Department
Who may be able to join
- Aged 18 years or above who are triage category 3 in emergency department
- Presenting to emergency department between 9am and 4pm, Monday to Friday
Who cannot join
- Aged below 18 years
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Triage Category 3 (Urgent)
- Keywords
- National Early Warning Score (NEWS), Lactate, Emergency Department
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days after recruitment
Secondary outcomes (6)
referral for intensive care unit (ICU) admission
Measured: 24 hr after recruitment
length of stay in hospital (LOS)
Measured: 30 days after recruitment
hospital admission
Measured: 30 days after recruitment
admission to ICU
Measured: 30 days after recruitment
length of ICU-free admission
Measured: 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
Measured: 24 hr after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion30 Jun 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triage Category 3 (Urgent)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Graham, Chinese University of Hong Kong
- Investigators
- Colin A Graham, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817581
- Sponsor's protocol ID
- CRE- 2016.236
- Status last verified
- Aug 2018
- First submitted
- 27 Jun 2016
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of National Early Warning Score (NEWS) and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT02817581
- Acronym / sponsor ID
- CRE- 2016.236
- Conditions
- Triage Category 3 (Urgent)
- Keywords
- National Early Warning Score (NEWS), Lactate, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or above who are triage category 3 presenting to Emergency Department
Key inclusion criteria (2 listed)
- Aged 18 years or above who are triage category 3 in emergency department
- Presenting to emergency department between 9am and 4pm, Monday to Friday
Key exclusion criteria (2 listed)
- Aged below 18 years
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day mortality
Time frame: 30 days after recruitment
6 secondary outcomes
referral for intensive care unit (ICU) admission
Time frame: 24 hr after recruitment
length of stay in hospital (LOS)
Time frame: 30 days after recruitment
hospital admission
Time frame: 30 days after recruitment
admission to ICU
Time frame: 30 days after recruitment
length of ICU-free admission
Time frame: 30 days after recruitment
time to processes-of-care
Time frame: 24 hr after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin A Graham, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triage Category 3 (Urgent), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.