TLR4-mediated release of heparin-binding protein in human airways: a co-stimulatory role for IL-26.
Magnus Paulsson, Eduardo I Cardenas, Karlhans F Che...
https://pubmed.ncbi.nlm.nih.gov/37234157Actively Recruiting
Age: 18Years +
All Genders
ID05117125
Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
Led by Region Skane · Updated on 2024-11-15
1000
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying ventilator-associated pneumonia (VAP) to identify peptide biomarkers, microbiome variations, and bacterial transcriptome patterns that could help predict or diagnose this condition. The study aims to better understand these biological markers and their potential role in managing VAP. The trial is observational and conducted by Region Skane, focusing on adults admitted to intensive care units who are mechanically ventilated. Participants are categorized into three groups: those who fully meet VAP criteria, those showing signs of VAP but missing some diagnostic features, and those who do not develop VAP. Several diagnostic tests are evaluated, including heparin-binding protein (HBP), interleukin-26 (IL-26), the lung microbiome, bacterial transcriptome, and proteome. The study measures changes in these markers over time, particularly on days 1, 3, 7, and 14 depending on the group. During the study, participants undergo sample collection and monitoring to assess biomarker levels, lung microbiome diversity, and bacterial transcriptome patterns at specified time points. Researchers track changes in HBP and IL-26 concentrations and compare values at VAP diagnosis versus non-VAP status. The study includes assessments on day 1 and day 3 for microbiome diversity and bacterial transcriptome on day 1 for VAP patients. Participation involves ICU stay and mechanical ventilation monitoring, with data collected to evaluate diagnostic and prognostic markers for VAP.
CONDITIONS
Brief Title
Biomarkers for Ventilator-associated Pneumonia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Admission to an intensive care unit
- Intubation within last 24 hours
- Anticipated mechanical ventilation of at least 48 hours
- Age 18 years or older
You will not qualify if you...
- FiO2 above 70% or PEEP above 15
- Severe coagulopathy (spontaneous PK(INR) >1.8 or thrombocytes <50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is allowed if not at higher doses without clinician consultation
- Ongoing lung infection at ICU admission
- Severely elevated or unstable intracranial pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 14 days
Participants undergo diagnostic tests including measurements of Heparin-binding protein, Interleukin-26, lung microbiome, bacterial transcriptome, and proteome to assess biomarkers for ventilator-associated pneumonia (VAP).
Visits on Day 1, Day 3, and for selected patients Day 7 and Day 14, with additional visits on VAP Day 1, 3, and 7 for participants with VAP.
Long-term Monitoring
Duration - Up to 14 days
Participants are monitored over time to observe changes in biomarker levels and clinical status related to VAP development and treatment outcomes.
Follow-up visits aligned with biomarker assessments on Day 1, 3, 7, and 14 depending on participant group.
Trial Site Locations
Total: 5 locations
1
Vestre Viken
Drammen, Norway, 3004
Actively Recruiting
2
Hospital de São Francisco Xavier
Lisbon, Portugal
Actively Recruiting
3
Skåne University Hospital, Dept. of Infectious diseases
Lund, Sweden
Actively Recruiting
4
Skåne university Hospital, ICU
Malmö, Sweden
Actively Recruiting
5
Karolinska University Hospital, ICU
Solna, Sweden
Not Yet Recruiting
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Research Team
M
Magnus Paulsson, PhD MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Heparin-binding protein in lower airway samples as a biomarker for pneumonia.
Magnus Paulsson, Louise Thelaus, Kristian Riesbeck...
https://pubmed.ncbi.nlm.nih.gov/34103069