Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active study of Sepsis and Delirium, Sepsis Associated, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Acute encephalopathy will be measured using the mental status assessment including the Delirium Triage Screen (DTS) Brief Confusion Assessment Method (bCAM). DTS-bCAM assessment is a flowchart that helps diagnose a patient who is altered.
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 |
What the registry record for NCT03133208 still lists
NCT03133208 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03133208's enrollment target sits among peer trials
90 59th of 90 higher than 32 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The APS Phenotyping Study
RECRUITING
-
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
RECRUITING · Phase 2
-
Early Versus Late Adjunctive Vasopressin in Septic Shock
RECRUITING · Phase 4
-
Renin Angiotensin Aldosterone System In Septic Kids
RECRUITING
-
The RightCall: Implementing a Sepsis Diagnostic Toolkit to Improve Pediatric Diagnosis in ED Transfer Calls
RECRUITING · NA
-
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI