The ASTERS Study: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome (ARDS)

NCT03654352 | Completed

• 1 other identifier: 44569
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 pathophysiology seen in this disease and may be a potential pharmacologic target for clinical treatment. Thus the purpose of this exploratory research is to maximize existing specimens to further evaluate ceramide as a biomarker for acute lung injury.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Keywords

lung; ceramide; sphingolipid; inflammation; pulmonary; ARDS; ALI

Outcome Measures

Primary Outcomes (1)

• Ceramide levels in exhaled breath condensate

  Ceramide is a candidate bio marker we plan to examine to describe patterns of risk factors associated with ARDS/ALI.

  We plan to do a single time point data collection. Exhaled breath will be collected for 20 minutes.

Study Arms (2)

High Risk for ARDS/ALI

Mechanically ventilated patients with risk factors for the development of ARDS/ALI. These factors are classified into two categories: pulmonary insults, such as pneumonia and extrapulmonary insults such as sepsis.

Low Risk for ARDS/ALI

Mechanically ventilated patients with low risk factors for the development of ARDS/ALI. These factors include mechanical ventilation for airway protection, pain management, or procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the medical intensive care unit

You may qualify if:

• Admission to the medical intensive care unit Mechanically ventilated for less than 48 hours Able to consent in English. -

You may not qualify if:

• Unable to obtain consent Mechanically ventilated for more than 48 hours Moribund Prisoner or ward of the state Pregnant Less than 18 years old, Metastatic lung cancer.

Sponsors & Collaborators

• Sturgill: lead

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: April 17, 2019
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)