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Markers of Inflammation and Metabolism in the ER

Markers of Inflammation and Metabolism in the ER

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03494790
Acronym
MIMER
Enrollment
955
Registered
2018-04-11
Start date
2017-12-15
Completion date
2019-08-01
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Infection, Sepsis

Keywords

MMP, Matrix metalloproteinase, Metabolomics, FGF-21, Quick SOFA, Infection, Triage

Brief 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. 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.

Interventions

None listed

Sponsors

University of Helsinki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age 18 or more Suspected or confirmed infection Admitted to any of the three emergency departments of university hospital Decision of blood culture

Exclusion criteria

Age \<18 Cancer with metastases Decision of treatment limitation probable or made Consent not obtainable

Design outcomes

Primary

MeasureTime frameDescription
Days alive without intensive care or high dependency unit treatment2 weeks from study admissionAccounts for patients who survive and need no ICU or high dependency care for the primary infection.

Secondary

MeasureTime frameDescription
30 day mortality30 daysNumber of patients who die within 30 days of admission
90 day mortality90 daysNumber of patients who die within 90 days aof admission

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026