Triage Category 3 (Urgent)NCT02694887
Capillary and Venous Lactate in Emergency Department Patients
An observational study of Triage Category 3 (Urgent), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of the present project is to study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample. 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
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2016to 20 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: Agreement Between Capillary and Venous Lactate in Emergency Department Patients
The objective of the present project is to study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Read the detailed description
Background:
Increase in lactate levels (hyperlactataemia) is common in critically ill patients and it is a sensitive marker in early identification of patients who are critically ill. Blood lactate is also a predictor of clinical outcomes. High level of lactate is associated with high mortality as well as increased morbidity. Capillary blood sample is easy to collect, less painful, and its measurement using handheld device which may allow more rapid determination of test results in ED. This rapid lactate measurement could aid early recognition of patients at high risk of mortality and morbidity. However, the accuracy of this rapid capillary lactate measurement using handheld devices has not been well studied in ED patients.
Objective:
To study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Study design:
This is a prospective observational study of patients presenting to ED of Prince of Wales Hospital (PWH). Patients aged 18 or above who are triage category 3 presenting to ED will be recruited. Capillary and venous blood samples will be collected. Venous lactate levels will be measured by blood gas analyzer (Siemens Automatic QC RAPID Systems RAPID Point@500) and two hand-held lactate analyzers (StatStrip Xpress Lactate Meter and Lactate Scout + ). Venous lactate levels measured by blood gas analyzer will be served as "reference method". Capillary lactate levels will be analyzed by handheld lactate analyzer. We are aimed to recruited 240 patients.
Outcomes:
The primary outcome is the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g. venepuncture blood gas analyzer sample. The secondary outcomes are: (1) compare the difference in values of venous lactate using blood gas analyzer and hand-held lactate analyzers, (2) compare values of capillary and venous lactate using hand-held lactate analyzers, (3) compare the reporting times of handheld and blood gas analyzer, and (4) Compare values of capillary lactate using between the two hand-held lactate analyzers.
- Conditions
- Triage Category 3 (Urgent)
- Keywords
- Capillary blood, Venous blood, Lactate, Emergency Department
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of capillary blood level measured by handheld lactate analyzer when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Measured: 30 minutes after recruitment
Secondary outcomes (4)
Value of venous lactate measured using blood gas analyzer and handheld lactate analyzers
Measured: 30 minutes after recruitment
Value of venous lactate and capillary lactate measured using handheld lactate analyzers
Measured: 30 minutes after recruitment
Reporting time of venous lactate level measured using blood gas analyzer and reporting time of capillary lactate using hand-held lactate analyzers
Measured: 30 minutes after recruitment
Value of capillary lactate measured using two hand-held lactate analyzers
Measured: 30 minutes after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion8 Feb 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 240 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
- NCT02694887
- Sponsor's protocol ID
- CRE- 2015.624
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2016
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Graham CA, Leung LY, Lo RS, Lee KH, Yeung CY, Chan SY, Cattermole GN, Hung KK. Agreement between capillary and venous lactate in emergency department patients: prospective observational study. BMJ Open. 2019 Apr 3;9(4):e026109. doi: 10.1136/bmjopen-2018-026109.
PubMed 30948594
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Capillary and Venous Lactate in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT02694887
- Acronym / sponsor ID
- CRE- 2015.624
- Conditions
- Triage Category 3 (Urgent)
- Keywords
- Capillary blood, Venous blood, Lactate, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 1 Mar 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.
The objective of the present project is to study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Detailed description
Background:
Increase in lactate levels (hyperlactataemia) is common in critically ill patients and it is a sensitive marker in early identification of patients who are critically ill. Blood lactate is also a predictor of clinical outcomes. High level of lactate is associated with high mortality as well as increased morbidity. Capillary blood sample is easy to collect, less painful, and its measurement using handheld device which may allow more rapid determination of test results in ED. This rapid lactate measurement could aid early recognition of patients at high risk of mortality and morbidity. However, the accuracy of this rapid capillary lactate measurement using handheld devices has not been well studied in ED patients.
Objective:
To study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Study design:
This is a prospective observational study of patients presenting to ED of Prince of Wales Hospital (PWH). Patients aged 18 or above who are triage category 3 presenting to ED will be recruited. Capillary and venous blood samples will be collected. Venous lactate levels will be measured by blood gas analyzer (Siemens Automatic QC RAPID Systems RAPID Point@500) and two hand-held lactate analyzers (StatStrip Xpress Lactate Meter and Lactate Scout + ). Venous lactate levels measured by blood gas analyzer will be served as "reference method". Capillary lactate levels will be analyzed by handheld lactate analyzer. We are aimed to recruited 240 patients.
Outcomes:
The primary outcome is the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g. venepuncture blood gas analyzer sample. The secondary outcomes are: (1) compare the difference in values of venous lactate using blood gas analyzer and hand-held lactate analyzers, (2) compare values of capillary and venous lactate using hand-held lactate analyzers, (3) compare the reporting times of handheld and blood gas analyzer, and (4) Compare values of capillary lactate using between the two hand-held lactate analyzers.
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
The accuracy of capillary blood level measured by handheld lactate analyzer when compared with the reference methods e.g.venepuncture blood gas analyzer sample.
Time frame: 30 minutes after recruitment
4 secondary outcomes
Value of venous lactate measured using blood gas analyzer and handheld lactate analyzers
Time frame: 30 minutes after recruitment
Value of venous lactate and capillary lactate measured using handheld lactate analyzers
Time frame: 30 minutes after recruitment
Reporting time of venous lactate level measured using blood gas analyzer and reporting time of capillary lactate using hand-held lactate analyzers
Time frame: 30 minutes after recruitment
Value of capillary lactate measured using two hand-held lactate analyzers
Time frame: 30 minutes 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 21 Mar 2023.
- Background: PubMed 30948594Graham CA, Leung LY, Lo RS, Lee KH, Yeung CY, Chan SY, Cattermole GN, Hung KK. Agreement between capillary and venous lactate in emergency department patients: prospective observational study. BMJ Open. 2019 Apr 3;9(4):e026109. doi: 10.1136/bmjopen-2018-026109.
- 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 21 Mar 2023. 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?
The accuracy of capillary blood level measured by handheld lactate analyzer when compared with the reference methods e.g.venepuncture blood gas analyzer sample. (time frame: 30 minutes after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694887, which also lists 1 linked publication.
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 21 Mar 2023.