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NCT03654352 · ClinicalTrials.gov registry record
The ASTERS Study: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome (ARDS)
A clinical trial of Acute Respiratory Distress Syndrome and Acute Lung Injury, sponsored by Sturgill.
- Completed
- Registry status
- 8
- Enrollment target
- 1
- Study location
NCT03654352 is a study of Acute Respiratory Distress Syndrome and Acute Lung Injury that has completed, run by Sturgill. The registered enrollment target is 8 participants, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03654352, a study of Acute Respiratory Distress Syndrome and Acute Lung Injury, has completed, sponsored by Sturgill.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
- 1
- Study location
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, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (98% lower). The listed sponsor is Sturgill, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT03654352 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
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.
Who is sponsoring clinical trial NCT03654352?
This trial is sponsored by Sturgill, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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