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

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ClinicalTrials.gov Identifier: NCT04097210
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Marja Mäkinen, Helsinki University Central Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Critical Illness 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.


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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: When Triage is Insufficient - the Benefit of Bedside CRP Within Ambulance Care
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018



Primary Outcome Measures :
  1. Number of patients with high suPAR level [ Time Frame: 24 hours ]
    A high suPAR level, e.g. above 6 ng/ml


Biospecimen Retention:   Samples Without DNA
No biospecimen banking


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Ages Eligible for Study:   16 Years to 104 Years   (Child, Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal vitals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097210


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Maaret Castrén, Professor Helsinki University Central Hospital
Principal Investigator: Johanna Kaartinen, PhD Helsinki University Central Hospital

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Responsible Party: Marja Mäkinen, PhD, principal investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04097210     History of Changes
Other Study ID Numbers: HUS 329/13/3/02/2015
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marja Mäkinen, Helsinki University Central Hospital:
Q-CRP
lactate
suPAR
POC
ambulance
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes