Impact of Point-of-care Lactate Testing as Triage Supplement on Patient Management Using Manchester Triage System

NCT07123857 | Recruiting

• 1 other identifier: IRP-2024/01-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Vasoactive drug use

  30-day

Secondary Outcomes (2)

• In-hospital mortality

  30-day

• ICU admission

  30-day

Study Arms (2)

Control group - No-retriage

NO INTERVENTION

Test group - Retriage to orange MTS group

EXPERIMENTAL

Diagnostic Test: re-triage

Interventions

re-triage DIAGNOSTIC_TEST

Patients in the test group will be re-triaged into the orange MTS category.

Test group - Retriage to orange MTS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed consent, yellow MTS triage category

You may not qualify if:

• pregnant women, trauma patients, epileptic seizures, adrenergic therapy in prehospital unit

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

University Medical Center Maribor

Maribor, Slovenia

RECRUITING

Central Study Contacts

Jerica Zaloznik Djordjevic, MD

CONTACT

00386 31 696 858; jerica.zalo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 14, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)