Lung Injury is One of the Primary Causes of Morbidity and Mortality in Critically Ill Patients. These Patients Will be Monitored for: 1) Immune Cell Activation 2) Blood-based Biomarkers. In Vitro Models Derived From These Samples Will be Treated With Novel Agent PIP-2 to Evaluate Its Efficacy.
ALI/ARDS
Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
1 other identifier
observational
36
1 country
1
Brief Summary
Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) is a condition where high levels of inflammation damage the lung. This is a highly morbid condition with no specific pharmacologic therapies. The investigators posit that ARDS is caused due to an exaggerated activation of immune cells and that blockade of this activation may reduce lung damage/injury and help in ARDS management and possibly recovery. To test this hypothesis, the investigators propose to generate an in vitro immune cell model and test a novel (reactive oxygen species) blocking agent PIP-2 on this model. The investigating team will obtain blood of ARDS patients and isolate immune cells (specifically peripheral blood mononuclear cells or PBMC) and monitor the activation of these cells and their blockade by PIP-2. This is entirely an in vitro study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2025
CompletedFirst Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 20, 2027
June 10, 2026
June 1, 2026
1.6 years
May 30, 2025
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reactive oxygen species in vitro
Peripheral Blood Mononuclear cells (PBMC) isolated
From enrollment until 21 days
Study Arms (1)
Subjects with ARDS
Eligibility Criteria
Patients admitted to the Hospital Of the University of Pennsylvania at the ICU.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Peroxitech Inccollaborator
Study Sites (1)
Hospital Of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shampa Chatterjee, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Christian Bermudez, MD
University of Pennsylvania
- STUDY DIRECTOR
Asad Usman, MD
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
August 15, 2025
Study Start
May 20, 2025
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
November 20, 2027
Last Updated
June 10, 2026
Record last verified: 2026-06