- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07123857
- Original Trial
Impact of Point-of-care Lactate Testing as Triage Supplement on Patient Management Using Manchester Triage System
August 7, 2025 updated by: University Medical Centre Maribor
Although the Manchester Triage System (MTS) is widely used and validated internationally, it has some limitations.
Its accuracy is moderate, especially for children and the elderly.
Rising patient numbers and overcrowded emergency departments increase wait times, sometimes beyond safe limits.
In Slovenia, MTS has been in use for 14 years without major updates, despite a significant rise in emergency visits.
The yellow triage category (60-minute wait time) includes a very diverse group of patients, some of whom might require faster care.
Older patients, in particular, often show atypical symptoms and may be under-triaged.
Including rapid bedside lab tests, like blood lactate levels, could improve risk assessment and triage accuracy.
Elevated lactate is linked with higher mortality and can help identify critically ill patients more effectively.
The proposed study is a prospective, randomized trial involving two groups of patients in the yellow triage category, all of whom will have their capillary blood lactate levels measured.
Patients with normal lactate levels will be excluded.
Only patients with elevated lactate will be compared.
The test group will be re-triaged to the orange category and treated more urgently.
The control group, despite also having high lactate levels, will remain in the yellow category, and their elevated lactate values will not be shared with the treating physician.
Randomization will be based on the patient's birth date (even days = test group, odd days = control group).
Only the nurse will know the result, maintaining physician blinding to avoid the Hawthorne effect-changes in behavior due to awareness of being studied.
Standard lab tests will be performed later during treatment as deemed necessary by the attending doctor.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jerica Zaloznik Djordjevic, MD
- Phone Number: 00386 31 696 858
- Email: jerica.zalo@gmail.com
Study Locations
-
-
-
Maribor, Slovenia
- Recruiting
- University Medical Center Maribor
-
Contact:
- Jerica Zaloznik Djordjevic, MD
- Phone Number: 00386 31 696 858
- Email: jerica.zalo@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- signed consent, yellow MTS triage category
Exclusion Criteria:
- pregnant women, trauma patients, epileptic seizures, adrenergic therapy in prehospital unit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group - No-retriage
|
|
|
Experimental: Test group - Retriage to orange MTS group
|
Patients in the test group will be re-triaged into the orange MTS category.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vasoactive drug use
Time Frame: 30-day
|
30-day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
In-hospital mortality
Time Frame: 30-day
|
30-day
|
|
ICU admission
Time Frame: 30-day
|
30-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 16, 2025
First Submitted That Met QC Criteria
August 7, 2025
First Posted (Estimated)
August 14, 2025
Study Record Updates
Last Update Posted (Estimated)
August 14, 2025
Last Update Submitted That Met QC Criteria
August 7, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRP-2024/01-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared with other researchers.
The decision not to share IPD is based on privacy concerns, data protection regulations, and institutional policy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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