Decision-making - the Benefit of Bedside CRP Within Ambulance Care (Q-CRP)

When Triage is Insufficient - the Benefit of Bedside CRP Within Ambulance Care

Patients with degreased (DGC) for ambiguous reasons receive low triage priority. Their death risk is triple. Tools are needed to identify the critically ill patients from this group. The triage used today is not effective. The bedside point-of-care measurements are CRP, lactate acid and suPAR (Soluble Urokinase Plasminogen Activator Receptor). Elevated values associate with the probability of critical illness and predict a risk of death.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Diagnostic test: POC

Detailed Description

Purpose: To improve identification and proper prioritization of patients with non-specific symptoms prehospitally, we intend to investigate whether Q-CRP, a rapid test for CRP, correlates with time-critical states in the above-mentioned patient group alone or together with CRP, lactate and suPAR. The primary endpoint is need for hospital care.

Material: Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Method: In patients with unspecified conditions, defined according to the inclusion template, a venous blood sample was taken prehospitally at the scene by the EMS.

Analysis: Significance tests and regression analyzes with 95% CI were used. The diagnostic accuracy of Q-CRP, lactate, suPAR and combinations thereof were compared with optimal boundary values.

• Study Type: Observational
• Enrollment (Actual): 110

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 104 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with degreased condition (DGC) over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Description

Inclusion Criteria:

• Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Exclusion Criteria:

• Abnormal vitals

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with high suPAR level	A high suPAR level, e.g. above 6 ng/ml	24 hours

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Maaret Castrén, Professor, Helsinki University Central Hospital; Principal Investigator: Johanna Kaartinen, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: lactate; ambulance; suPAR; POC; Q-CRP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HUS 329/13/3/02/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No