TriageNCT07123857
Impact of Point-of-care Lactate Testing as Triage Supplement on Patient Management Using Manchester Triage System
A study testing re-triage in people with Triage and Emergency Department Triage, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triage, Emergency Department Triage, Emergency Department Overcrowding
- What is being tested?
- re-triage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- signed consent, yellow MTS triage category
Who cannot join
- pregnant women, trauma patients, epileptic seizures, adrenergic therapy in prehospital unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Maribor
Maribor
Jerica Zaloznik Djordjevic, MD, 00386 31 696 858, jerica.zalo@gmail.com
About this study
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.
- Conditions
- Triage, Emergency Department Triage, Emergency Department Overcrowding, Emergency Medicine
- Being tested
- re-triage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-triageDiagnostic test
Patients in the test group will be re-triaged into the orange MTS category.
| Study group | Role | What they receive |
|---|---|---|
| Control group - No-retriage | No intervention | Not described |
| Test group - Retriage to orange MTS group | Experimental | Not described Receives: Diagnostic Test: re-triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoactive drug use
Measured: 30-day
Secondary outcomes (2)
In-hospital mortality
Measured: 30-day
ICU admission
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start10 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TriageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123857
- Sponsor's protocol ID
- IRP-2024/01-13
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Point-of-care Lactate Testing as Triage Supplement on Patient Management Using Manchester Triage System
- ClinicalTrials.gov ID
- NCT07123857
- Acronym / sponsor ID
- IRP-2024/01-13
- Conditions
- Triage, Emergency Department Triage, Emergency Department Overcrowding, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2025 (actual)
- 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - No-retriage | No intervention | – |
| Test group - Retriage to orange MTS group | Experimental | Diagnostic Test: re-triage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed consent, yellow MTS triage category
Key exclusion criteria (1 listed)
- pregnant women, trauma patients, epileptic seizures, adrenergic therapy in prehospital unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| re-triagePatients in the test group will be re-triaged into the orange MTS category. | Diagnostic test | Test group - Retriage to orange MTS group |
Primary outcome
Vasoactive drug use
Time frame: 30-day
2 secondary outcomes
In-hospital mortality
Time frame: 30-day
ICU admission
Time frame: 30-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing re-triage in people with Triage and Emergency Department Triage, run by University Medical Centre Maribor at 1 site in Slovenia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerica Zaloznik Djordjevic, MD (00386 31 696 858, jerica.zalo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasoactive drug use (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.