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

NCT ID: NCT07123857

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Control group - No-retriage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Test group - Retriage to orange MTS group

Group Type: EXPERIMENTAL

re-triage

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

re-triage

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• signed consent, yellow MTS triage category

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Maribor

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Maribor

Maribor, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Jerica Zaloznik Djordjevic, MD

Role: CONTACT

jerica.zalo@gmail.com

00386 31 696 858

Facility Contacts

Jerica Zaloznik Djordjevic, MD

Role: primary

jerica.zalo@gmail.com

00386 31 696 858

Other Identifiers

IRP-2024/01-13

Identifier Type: -

Identifier Source: org_study_id