Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02694887 |
| Other study ID # |
CRE- 2015.624 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
