NCT03812666

Search for Biomarkers of Infection and Inflammation in Patients With Acute Stroke.

Inflammatory Biomarkers In Stroke - Discovery Phase

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Jakob Ström · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. Patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days.

Detailed description

Rationale: Stroke is one of the leading causes of death globally, and infections after stroke contribute to a large part of the stroke-related mortality. The current study, which has a prospective, observational design, constitutes the second phase out of four in the Inflammatory Biomarkers In Stroke (IBIS) project, of which the overall goal is to enable early treatment of post-stroke infections. Aim: To develop a combined clinical and molecular biological signature for early detection of pneumonia in patients with stroke. Design: Prospective nested case control study Methods:Patients (n=200) with acute stroke will be monitored with clinical examinations for ten days and by daily blood samples for seven days. When cases of pneumonia have been established, samples and examination results from days preceding overt pneumonia will be compared to samples from similar patients that did not develop pneumonia. Outcome: Using proteomic and metabolomic methods, novel markers of upcoming pneumonia after stroke will be sought. Such laboratory markers will be combined with current biomarkers (such as C-reactive protein and procalcitonin) and data from clinical examinations, with the aim of constructing a biological signature that enables early detection of pneumonia.

Conditions

• Stroke, Acute
• Pneumonia, Bacterial

Timeline

• Start date: 2019-01-15
• Primary completion: 2023-07-01
• Completion: 2025-07-01
• First posted: 2019-01-23
• Last updated: 2023-11-18

Locations

1 site across 1 country: Sweden