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Capillary and Venous Lactate in Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT02694887
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Colin Graham, Chinese University of Hong Kong

Study Description
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Brief 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.

Condition or disease
Triage Category 3 (Urgent)

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
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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Agreement Between Capillary and Venous Lactate in Emergency Department Patients
Study Start Date : March 2016
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : December 20, 2017
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Value of venous lactate measured using blood gas analyzer and handheld lactate analyzers [ Time Frame: 30 minutes after recruitment ]
  2. Value of venous lactate and capillary lactate measured using handheld lactate analyzers [ Time Frame: 30 minutes after recruitment ]
  3. 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 ]
  4. Value of capillary lactate measured using two hand-held lactate analyzers [ Time Frame: 30 minutes after recruitment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 or above who are triage category 3 presenting to Emergency Department
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694887


Locations
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Hong Kong
Prince of Wales Hospital
Sha Tin, NT, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Colin A Graham, MD Chinese University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Colin Graham, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02694887    
Other Study ID Numbers: CRE- 2015.624
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Colin Graham, Chinese University of Hong Kong:
Capillary blood
Venous blood
Lactate
Emergency Department
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes