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Completed

NCT Number: NCT03494790

Markers of Inflammation and Metabolism in the ER

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 30 day mortality

    Time frame: 30 days

    Number of patients who die within 30 days of admission

  2. 90 day mortality

    Time frame: 90 days

    Number of patients who die within 90 days aof admission

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Acronym: MIMER

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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