Critical IllnessQ-CRPNCT04097210
Decision-making - the Benefit of Bedside CRP Within Ambulance Care
An observational study of Critical Illness, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 104 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- POC
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 104 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with degreased condition (DGC) over 18 years who exhibit non-specific symptoms and transported to the emergency room.
Who may be able to join
- Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.
Who cannot join
- Abnormal vitals
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- POC
- Keywords
- Q-CRP, lactate, suPAR, POC, ambulance
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with high suPAR level
A high suPAR level, e.g. above 6 ng/ml
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jan 2016
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marja Mäkinen, Helsinki University Central Hospital
- Investigators
- Maaret Castrén, Professor, Study director, Helsinki University Central HospitalJohanna Kaartinen, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097210
- Sponsor's protocol ID
- HUS 329/13/3/02/2015
- Acronym
- Q-CRP
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Triage is Insufficient - the Benefit of Bedside CRP Within Ambulance Care
- ClinicalTrials.gov ID
- NCT04097210
- Acronym / sponsor ID
- Q-CRP / HUS 329/13/3/02/2015
- Conditions
- Critical Illness
- Keywords
- Q-CRP, lactate, suPAR, POC, ambulance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 20 Sep 2019 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 104 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with degreased condition (DGC) over 18 years who exhibit non-specific symptoms and transported to the emergency room.
Key inclusion criteria (1 listed)
- Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.
Key exclusion criteria (1 listed)
- Abnormal vitals
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 |
|---|---|---|
| POC | Diagnostic test | – |
Primary outcome
Number of patients with high suPAR level
Time frame: 24 hours
A high suPAR level, e.g. above 6 ng/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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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. This study is not recruiting at the moment.
Maaret Castrén, Professor study director
Helsinki University Central Hospital
Johanna Kaartinen, PhD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Helsinki University Central Hospital.
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: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with high suPAR level (time frame: 24 hours). 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 31 Jan 2022.