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.
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT07125079
- Status
- Recruiting
Conditions
- ARDS (Acute Respiratory Distress Syndrome)
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 90 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 20, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 20, 2026
- Completion
- Nov 20, 2027
Study Design
- Enrollment
- 36 participants (estimated)
Arms
- Arm: Subjects with ARDS
Primary Outcome Measure
Reactive oxygen species in vitro [ Time Frame: From enrollment until 21 days ]
Central Contacts
- Shampa Chatterjee, PhD215-898-9101
- Christian Bermudez, MD215-615-5864
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hospital Of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | - |
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