Markers of Inflammation and Metabolism in the ER (MIMER)

February 11, 2020 updated by: Johanna Hastbacka, University of Helsinki
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

955

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks from study admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day mortality
Time Frame: 30 days
Number of patients who die within 30 days of admission
30 days
90 day mortality
Time Frame: 90 days
Number of patients who die within 90 days aof admission
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelsinkiU1423/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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