The APS Phenotyping Study

Recruiting at 18 trial locations

Overseen by Wesley H. Self, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. This study will also generate a biobank of specimens collected from these patients that will be available to investigators for future studies of ARDS, sepsis, and/or pneumonia.

Research Team

Wesley H. Self, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

I am 18 years old or older.

I am in or going to be in an ICU or similar unit where I can receive advanced breathing support or IV pressure medication.

I recently started using a ventilator or oxygen for severe shortness of breath.

Treatment Details

Participant Groups

Group I: Long-term Outcomes Cohort Experimental Treatment 11 Interventions

The Long-term Outcomes Cohort consists of a subset of participants with written informed consent for study participation (Cohort A) who complete in-person post-hospital study assessments. These in-person study visits are scheduled at 3-, 6-, and 12-months after initial enrollment in the hospital. Interventions/exposures are denoted for this group for study procedures that are completed during an in-person post-hospital visit.

Group II: Cohort B (alteration study protocol - alteration of informed consent) Experimental Treatment 6 Interventions

Cohort B is the cohort of APS study participants who are enrolled in the study under alteration of informed consent. Cohort B will participate in a modified set of procedures which omits procedures considered greater than minimal risk.

Group III: Cohort A (full study protocol - written informed consent) Experimental Treatment 8 Interventions

Cohort A is the cohort of APS study participants who have provided written informed consent for participation in the APS phenotyping study. Cohort A may participate in all study procedures in the APS phenotyping study.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia