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Markers of Inflammation and Metabolism in the ER (MIMER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494790
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Johanna Hastbacka, University of Helsinki

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.

Condition or disease
Acute Infection Sepsis

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.

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Study Type : Observational
Actual Enrollment : 955 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Markers of Inflammation and Metabolism in the ER
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Serum sample 10ml Plasma lactate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494790


Locations
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Finland
Helsinki University Hospital
Helsinki, Finland
Sponsors and Collaborators
University of Helsinki
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Responsible Party: Johanna Hastbacka, MD,PhD, University of Helsinki
ClinicalTrials.gov Identifier: NCT03494790    
Other Study ID Numbers: HelsinkiU1423/2017
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johanna Hastbacka, University of Helsinki:
MMP
Matrix metalloproteinase
Metabolomics
FGF-21
Quick SOFA
Infection
Triage
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes