The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other, Radiation, Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ To be eligible for enrollment, a patient must meet all the following inclusion criteria at the time of the first study-specified biospecimen collection (Time 0):

• Age ≥ 18 years old

• Admitted (or planned to be admitted) to an intensive care unit (ICU) or other in-patient hospital location where IV vasopressors or advanced respiratory support (invasive mechanical ventilation, non-invasive ventilation, or high flow nasal cannula) are routinely provided (referred to as an eligible unit.)

• Acute cardiovascular or pulmonary organ dysfunction defined by meeting at least one of the two criteria below:

‣ New receipt of invasive mechanical ventilation, non-invasive ventilation, high flow nasal cannula, or supplemental oxygen at a flow rate of ≥ 6 lpm for acute hypoxemia.

‣ a. Patients who use chronic oxygen therapy are eligible to participate if they are receiving at least 6 lpm higher than their baseline oxygen requirement (e.g., a patient on 3 lpm O2 at baseline is eligible if they require ≥9 lpm for hypoxemia) or are started on advanced respiratory support (invasive mechanical ventilation, non- invasive ventilation, or high flow nasal cannula).

⁃ Receipt of intravenous infusion of a vasopressor medication for at least one hour.

• Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) is attributed to an acute inflammatory condition, including but not limited to any of the following:

‣ Any infection including pneumonia.

⁃ Aspiration pneumonitis.

⁃ Pancreatitis.

⁃ Auto-inflammatory condition such as:

• Hemophagocytic lymphohistiocytosis.

∙ Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.

∙ Suspected cryptogenic organizing pneumonia presenting acutely.

∙ Suspected diffuse alveolar hemorrhage.

∙ Suspected acute anaphylaxis.

∙ Suspected acute pulmonary drug toxicity.

Locations
United States
California
Fresno Community Hospital and Medical Center
NOT_YET_RECRUITING
Fresno
Stanford University
NOT_YET_RECRUITING
Palo Alto
San Francisco General Hospital
NOT_YET_RECRUITING
San Francisco
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Colorado
Denver Health and Hospital Authority
NOT_YET_RECRUITING
Denver
National Jewish Health
NOT_YET_RECRUITING
Denver
University of Colorado, Denver
RECRUITING
Denver
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Maryland
Johns Hopkins Univeristy
NOT_YET_RECRUITING
Baltimore
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Tennessee
Meharry Medical College
NOT_YET_RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Wesley H. Self, MD, MPH
wesley.self@vumc.org
1-615-936-8047
Backup
Jillian P. Rhoads, PhD
jillian.p.rhoads.1@vumc.org
1-615-936-3773
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 4000
Treatments
Cohort A (full study protocol - written informed consent)
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.
Cohort B (alteration study protocol - alteration of informed consent)
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.
Long-term Outcomes Cohort
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.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov