Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654352
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sturgill, University of Kentucky

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.

Condition or disease
Acute Lung Injury Acute Respiratory Distress Syndrome

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort
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.



Primary Outcome Measures :
  1. Ceramide levels in exhaled breath condensate [ Time Frame: We plan to do a single time point data collection. Exhaled breath will be collected for 20 minutes. ]
    Ceramide is a candidate bio marker we plan to examine to describe patterns of risk factors associated with ARDS/ALI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the medical intensive care unit
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654352


Contacts
Layout table for location contacts
Contact: Jamie L Sturgill, PhD 859-323-7277 jlstur0@uky.edu
Contact: Peter E Morris, MD 859-323-5045 peter.morris@uky.edu

Locations
Layout table for location information
United States, Kentucky
University of Kentucky Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Jamie S Sturgill, PhD    859-323-7277    jlstur0@uky.edu   
Sponsors and Collaborators
University of Kentucky

Layout table for additonal information
Responsible Party: Sturgill, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03654352     History of Changes
Other Study ID Numbers: 44569
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sturgill, University of Kentucky:
lung
ceramide
sphingolipid
inflammation
pulmonary
ARDS
ALI
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries