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The ASTERS Study: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome (ARDS)
NCT03654352 · View on ClinicalTrials.gov ↗
Study Summary
Acute lung injury (ALI) and the more severe manifestation, acute respiratory distress syndrome (ARDS) describe syndromes of acute onset, bilateral, inflammatory pulmonary infiltrates and impaired oxygenation. ARDS/ALI are a continuum of disease which results in a life threatening, rapidly progressive illness and occurs in critically ill patients. Recent reports in the Journal of the American Medical Association (JAMA) highlight the significant public health impact ARDS/ALI has on the critically ill population in that despite robust research efforts, these illnesses continue to be under diagnosed, under treated, and continue to have a high mortality rate (≥ 40% of all confirmed diagnoses). The estimates for ARDS/ALI incidence vary due to inconsistencies with proper diagnosis and lack of valid biomarkers of disease; however, it is expected that anywhere from 20-50% of patients on mechanical ventilation will develop this disease. Previous work by our group has shown that sphingolipids play a multifaceted role in lung inflammation. Sphingolipid are a class of bioactive lipids that play a role in cellular processes such as apoptosis, cell migration, and adhesion. Ceramide is one species of sphingolipid the investigators have examined in both man and mouse. Our laboratory has shown that ceramide is up-regulated in pulmonary inflammation in mouse models of pneumonitis and is elevated in the exhaled breath condensate of mechanically ventilated patients at risk for ARDS/ALI. Our work coupled with the work of others highlighting a role for ceramide in chronic obstructive pulmonary disease (COPD), surfactant dysfunction, and infectious disease make ceramide a logical candidate biomarker that warrants further investigation. To our knowledge, there are no studies examining the role of ceramide as a biomarker in ARDS/ALI. Thus, our overarching hypothesis is that ceramide is elevated in the lungs of patients who develop ARDS/ALI. This lipid dysregulation accounts for the pathophys
Conditions Studied
Study Locations (1)
Kentucky
- University of Kentucky Chandler Medical Center — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2021-03-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03654352
The ClinicalTrials.gov registry entry for NCT03654352 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sturgill, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03654352 reports 1 study location spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03654352 about?
NCT03654352 is a clinical study titled "The ASTERS Study: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome (ARDS)". Acute lung injury (ALI) and the more severe manifestation, acute respiratory distress syndrome (ARDS) describe syndromes of acute onset, bilateral, inflammatory pulmonary infiltrates and impaired oxygenation. ARDS/ALI are a continuum of disease which results in a life threatening, rapidly progressiv...
What is the current status of trial NCT03654352?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2019-04-17. Estimated completion is 2021-03-12.
What conditions does trial NCT03654352 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Acute Lung Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03654352?
This trial is sponsored by Sturgill, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03654352 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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