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NCT03133208 · ClinicalTrials.gov registry record
Sepsis Associated Encephalopathy (SAE) Biomarkers
A clinical trial of Sepsis and Delirium, Sepsis Associated, sponsored by University of Florida.
- Active
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT03133208 is a study of Sepsis and Delirium, Sepsis Associated that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 90 participants, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03133208, a study of Sepsis and Delirium, Sepsis Associated, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
Sepsis associated encephalopathy (SAE) is a poorly understood acute cerebral dysfunction that frequently appears in the setting of sepsis induced systemic inflammation. In fact, altered mentation is recognized as an independent predictor of death and poor outcomes in patients with sepsis. SAE may be manifested by a number of symptoms characterized by a change in baseline behavior, attention, alertness, cognition, or executive functioning. It occurs in the absence of direct Central Nervous System (CNS) infection, and the exact pathophysiology is of SAE is unknown, but theoretically seems to encompass a constellation of mechanisms such as impairment of the blood brain barrier (BBB), endothelial dysfunction, alteration in cerebral blood flow and neurotransmission, circulating inflammatory mediators, cellular hypoxia, and metabolic disturbances, that ultimately result in neuronal dysfunction and cell death. SAE is characterized by an altered mental status (AMS) that ranges from delirium to coma, and can lead to long-term cognitive impairment. SAE may appear early in the course of sepsis, and is often underestimated as an independent factor of mortality, yet the pathophysiology of SAE remains unknown, and there is a lack of specific investigations available to clinicians. Studies have evaluated biomarkers as prognostic tools. The Investigator propose to measure neuron specific enolase (NSE), S-100B, glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), Tau protein, Copeptin, spectrin breakdown products (SBDP 145, SBDP150), αII-spectrin N-terminal fragment (SNTF), neurofilament light and heavy chains (NF-L, NF-H), myelin basic protein (MBP), secretoneurin (SN), and other peptide levels in the serum of sepsis patients who develop altered mental status, to evaluate the kinetics of said biomarkers for 72 hours. The Investigator will monitor the course of the patients' hospitalization to determine whether there are biomarker correlates with survi
Conditions Studied
Interventions
- PROCEDURE Blood draws
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2026-12-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03133208
The ClinicalTrials.gov registry entry for NCT03133208 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Blood draws is the first listed.
NCT03133208 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03133208 about?
NCT03133208 is a clinical study titled "Sepsis Associated Encephalopathy (SAE) Biomarkers". Sepsis associated encephalopathy (SAE) is a poorly understood acute cerebral dysfunction that frequently appears in the setting of sepsis induced systemic inflammation. In fact, altered mentation is recognized as an independent predictor of death and poor outcomes in patients with sepsis. SAE may be...
What is the current status of trial NCT03133208?
This trial is currently active not recruiting. The enrollment target is 90 participants. The study started on 2017-06-01. Estimated completion is 2026-12-15.
What conditions does trial NCT03133208 study?
This clinical trial studies the following conditions: Sepsis, Delirium, Sepsis Associated, Altered Mental Status, Sepsis-Associated Delirium, Sepsis Associated Encephalopathy.
What interventions are being tested in trial NCT03133208?
The interventions under investigation include: Blood draws (PROCEDURE).
Who is sponsoring clinical trial NCT03133208?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03133208 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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