Acute InfectionMIMERNCT03494790
Markers of Inflammation and Metabolism in the ER
An observational study of Acute Infection and Sepsis, run by University of Helsinki at 1 site in Finland.
Trial summary
Adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. Blood samples are collected for the analysis of matrix metalloproteinases (MMP) and their inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Infection, Sepsis
- How many people
- 955 participants
- Where
- 1 siteFinland
- Study dates
- 15 Dec 2017to 1 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients that are admitted to the participating emergency departments, with suspected or confirmed acute infection. A decision of taking a blood culture sample is a surrogate for suspected severe infection.
Who may be able to join
- Age 18 or more Suspected or confirmed infection Admitted to any of the three emergency departments of university hospital Decision of blood culture
Who cannot join
- Age <18 Cancer with metastases Decision of treatment limitation probable or made Consent not obtainable
Trial locations and contacts
1 site in 1 country.
About this study
Adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. Blood samples are collected for the analysis of matrix metalloproteinases (MMP) and their inhibitors. We also aim to analyse metabolic changes and use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21 (FGF-21) as well. The primary aim of the study is to test the performance of MMP-8 in finding severely ill patients who will need treatment in high dependency unit or intensive care. The secondary aim is to study the metabolic changes in acutely ill patients with infection.
Read the detailed description
Adult patients with suspected or confirmed infection and who will be sampled for blood culture (a surrogate for suspected severe infection) will be recruited from three large emergency departments in a University hospital. Two blood samples will be collected: one for the analysis of matrix metalloproteinases, their inhibitor tissue inhibitor of metalloproteinase-1 (TIMP-1), FGF-21 and metabolomic analyses. Another blood sample is for the analysis of blood lactate. Clinical data will be collected to calculate quick SOFA (qSOFA), in order to test whether lactate and/or MMP-8 will improve the prognostic model if they are added to qSOFA. The primary outcome measure is the number of days alive without the need for ICU or high dependency unit treatment. The ability of MMP-8 to discriminate severe infection from uneventful course of the disease will be studied. The secondary aim is to study the metabolic changes in acutely ill patients with infection and compare these variables between survivors and non-survivors. The planned number of patients recruited is 924. During this study the feasibility of a bedside rapid analysis of MMP-8 will be tested in 30 patients and the results obtained using the rapid analyser compared with laboratory results obtained using ELISA.
- Conditions
- Acute Infection, Sepsis
- Keywords
- MMP, Matrix metalloproteinase, Metabolomics, FGF-21, Quick SOFA, Infection, Triage
- Medical subject headings
- Sepsis, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive without intensive care or high dependency unit treatment
Accounts for patients who survive and need no ICU or high dependency care for the primary infection.
Measured: 2 weeks from study admission
Secondary outcomes (2)
30 day mortality
Number of patients who die within 30 days of admission
Measured: 30 days
90 day mortality
Number of patients who die within 90 days aof admission
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start15 Dec 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 955 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Hastbacka, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494790
- Sponsor's protocol ID
- HelsinkiU1423/2017
- Acronym
- MIMER
- Status last verified
- Feb 2020
- First submitted
- 4 Apr 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Inflammation and Metabolism in the ER
- ClinicalTrials.gov ID
- NCT03494790
- Acronym / sponsor ID
- MIMER / HelsinkiU1423/2017
- Conditions
- Acute Infection, Sepsis
- Keywords
- MMP, Matrix metalloproteinase, Metabolomics, FGF-21, Quick SOFA, Infection, Triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 11 Apr 2018 (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.
Adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. Blood samples are collected for the analysis of matrix metalloproteinases (MMP) and their inhibitors. We also aim to analyse metabolic changes and use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21 (FGF-21) as well. The primary aim of the study is to test the performance of MMP-8 in finding severely ill patients who will need treatment in high dependency unit or intensive care. The secondary aim is to study the metabolic changes in acutely ill patients with infection.
Detailed description
Adult patients with suspected or confirmed infection and who will be sampled for blood culture (a surrogate for suspected severe infection) will be recruited from three large emergency departments in a University hospital. Two blood samples will be collected: one for the analysis of matrix metalloproteinases, their inhibitor tissue inhibitor of metalloproteinase-1 (TIMP-1), FGF-21 and metabolomic analyses. Another blood sample is for the analysis of blood lactate. Clinical data will be collected to calculate quick SOFA (qSOFA), in order to test whether lactate and/or MMP-8 will improve the prognostic model if they are added to qSOFA. The primary outcome measure is the number of days alive without the need for ICU or high dependency unit treatment. The ability of MMP-8 to discriminate severe infection from uneventful course of the disease will be studied. The secondary aim is to study the metabolic changes in acutely ill patients with infection and compare these variables between survivors and non-survivors. The planned number of patients recruited is 924. During this study the feasibility of a bedside rapid analysis of MMP-8 will be tested in 30 patients and the results obtained using the rapid analyser compared with laboratory results obtained using ELISA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients that are admitted to the participating emergency departments, with suspected or confirmed acute infection. A decision of taking a blood culture sample is a surrogate for suspected severe infection.
Key inclusion criteria (1 listed)
- Age 18 or more Suspected or confirmed infection Admitted to any of the three emergency departments of university hospital Decision of blood culture
Key exclusion criteria (1 listed)
- Age <18 Cancer with metastases Decision of treatment limitation probable or made Consent not obtainable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Days alive without intensive care or high dependency unit treatment
Time frame: 2 weeks from study admission
Accounts for patients who survive and need no ICU or high dependency care for the primary infection.
2 secondary outcomes
30 day mortality
Time frame: 30 days
90 day mortality
Time frame: 90 days
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 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Infection and Sepsis, run by University of Helsinki at 1 site in Finland.
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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Days alive without intensive care or high dependency unit treatment (time frame: 2 weeks from study admission). 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 10 Dec 2024.