Sepsis Associated Encephalopathy (SAE) Biomarkers
- Conditions
- SepsisAltered Mental StatusSepsis-Associated DeliriumSepsis Associated EncephalopathyDelirium, Sepsis Associated
- Registration Number
- NCT03133208
- Lead Sponsor
- University of Florida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Cohort 1:<br><br> - = 18 years old<br><br> - Presented to the emergency department at Shands<br><br> - Has not donated blood within the last 8 weeks<br><br> - Willing to participate and follow up at 6 months after discharge from the hospital<br><br> - Not anemic or have any other hematological disorders that requires transfusions<br><br>Meets two or more Systemic Inflammatory Response Syndrome (SIRS) criteria:<br><br> - Temperature >38°C or <36°C<br><br> - Heart rate (HR) > 90bpm<br><br> - Respiratory rate (RR) > 20bpm or partial pressures of carbon dioxide (PaCO2) <32mm<br> mercury (HG)<br><br> - White Blood Cell (WBC) >12,000/µL or < 4,000/µL or >10% immature/ bands Clinical<br> suspicion of sepsis (blood cultures ordered/ antibiotics started) Altered mental<br> status Enrolled within 6 hours of ED presentation<br><br>Cohort 2<br><br> - = 18 years old<br><br> - Presented to the emergency department at Shands<br><br> - Has not donated blood within the last 8 weeks<br><br> - Willing to participate and follow up at 6 months after discharge from the hospital<br><br> - Not anemic or have any other hematological disorders that requires transfusions<br><br>Meets two or more SIRS criteria:<br><br> - Temperature >38°C or <36°C<br><br> - HR > 90bpm<br><br> - RR > 20bpm or PaCO 2 <32mmHG<br><br> - WBC >12,000/µL or < 4,000/µL or >10% immature/ bands Clinical suspicion of sepsis<br> (blood cultures ordered/ antibiotics started) No altered mental status Enrolled<br> within 6 hours of ED presentation<br><br>Cohort 3 (control)<br><br> - Does not meet SIRS criteria<br><br> - No clinical suspicion of sepsis (no cultures/ antibiotics ordered)<br><br> - Not altered<br><br> - Patient has admission orders<br><br>Exclusion Criteria (all cohorts):<br><br> - Participating in another interventional, therapeutic study that may affect the<br> results of this study<br><br> - Subject has neurodegenerative disease or other neurological disorder (dementia,<br> Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumours)<br><br> - History of neurosurgery within the last 30 days<br><br> - Acute brain injury within the last 30 days (ischemic/ haemorrhagic stroke, traumatic<br> brain injury)<br><br> - Subject is anemic OR donated blood within the last 8 weeks OR has a hematological<br> disorder that requires transfusions<br><br> - Subject has history of liver failure OR renal failure<br><br> - Pregnant or lactating female
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship between biomarkers and neurological outcome- Delirium;Relationship between biomarkers and neurological outcome - Blessed
- Secondary Outcome Measures
Name Time Method Relationship between biomarkers and organ dysfunction;Relationship between biomarkers and overall survival;Degree of neurological impairment;Degree of neurological impairment