Can a simple blood test predict brain injury in sepsis?
NCT ID NCT03133208
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at blood markers in 90 sepsis patients who develop confusion or delirium. Researchers will take blood samples over 72 hours to measure proteins linked to brain injury. The goal is to find patterns that predict recovery or long-term problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors identify brain injury in sepsis patients earlier and predict recovery.
- What could go wrong
- This is an observational study with no treatment being tested. It may not lead to any direct benefit for patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who present to UF Health Shands emergency department with sepsis. The sepsis cohort will be further broken down into sub- cohorts: * Cohort 1: Patients who present with altered mental status * Cohort 2: Patients who do not present with altered mental status A control cohort (cohort 3) will include patients presenting to the ED with no suspicion of systemic inflammation that need hospitalization.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Cohort 1: * ≥ 18 years old * Presented to the emergency department at Shands * Has not donated blood within the last 8 weeks * Willing to participate and follow up at 6 months after discharge from the hospital * Not anemic or have any other hematological disorders that requires transfusions Meets two or more Systemic Inflammatory Response Syndrome (SIRS) criteria: * Temperature \>38°C or \<36°C * Heart rate (HR) \> 90bpm * Respiratory rate (RR) \> 20bpm or partial pressures of carbon dioxide (PaCO2) \<32mm mercury (HG) * White Blood Cell (WBC) \>12,000/µL or \< 4,000/µL or \>10% immature/ bands Clinical suspicion of sepsis (blood cultures ordered/ antibiotics started) Altered mental status Enrolled within 6 hours of ED presentation Cohort 2 * ≥ 18 years old * Presented to the emergency department at Shands * Has not donated blood within the last 8 weeks * Willing to participate and follow up at 6 months after discharge from the hospital * Not anemic or have any other hematological disorders that requires transfusions Meets two or more SIRS criteria: * Temperature \>38°C or \<36°C * HR \> 90bpm * RR \> 20bpm or PaCO 2 \<32mmHG * WBC \>12,000/µL or \< 4,000/µL or \>10% immature/ bands Clinical suspicion of sepsis (blood cultures ordered/ antibiotics started) No altered mental status Enrolled within 6 hours of ED presentation Cohort 3 (control) * Does not meet SIRS criteria * No clinical suspicion of sepsis (no cultures/ antibiotics ordered) * Not altered * Patient has admission orders Exclusion Criteria (all cohorts): * Participating in another interventional, therapeutic study that may affect the results of this study * Subject has neurodegenerative disease or other neurological disorder (dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumours) * History of neurosurgery within the last 30 days * Acute brain injury within the last 30 days (ischemic/ haemorrhagic stroke, traumatic brain injury) * Subject is anemic OR donated blood within the last 8 weeks OR has a hematological disorder that requires transfusions * Subject has history of liver failure OR renal failure * Pregnant or lactating female
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Florida
Gainesville, Florida, 32611, United States
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Other studies related to the condition(s) this trial covers.
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