Markers of Inflammation and Metabolism in the ER

NCT03494790 | Completed

• 1 other identifier: HelsinkiU1423/2017
• Study Type: observational
• Target: 955
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Infection; Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks from study admission

Secondary Outcomes (2)

• 30 day mortality

  30 days

• 90 day mortality

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample 10ml Plasma lactate

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: December 15, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 10, 2024

Record last verified: 2020-02

Locations

FI (1)