Capillary and Venous Lactate in Emergency Department Patients

Triage Category 3 (Urgent) Clinical Trial

Official title:

Agreement Between Capillary and Venous Lactate in Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694887
• Other study ID #: CRE- 2015.624
• Status: Completed
• Start date: March 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 20, 2017
• Est. primary completion date: February 8, 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, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of capillary blood level measured by handheld lactate analyzer when compared with the reference methods e.g.venepuncture blood gas analyzer sample.		30 minutes after recruitment
Secondary	Value of venous lactate measured using blood gas analyzer and handheld lactate analyzers		30 minutes after recruitment
Secondary	Value of venous lactate and capillary lactate measured using handheld lactate analyzers		30 minutes after recruitment
Secondary	Reporting time of venous lactate level measured using blood gas analyzer and reporting time of capillary lactate using hand-held lactate analyzers		30 minutes after recruitment
Secondary	Value of capillary lactate measured using two hand-held lactate analyzers		30 minutes after recruitment