RECRUITING

The APS Phenotyping Study

Conditions

ARDS Sepsis Pneumonia acute respiratory distress syndrome phenotype endotype critical illness

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-25

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06521502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years old 2. 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.") 3. 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. * Receipt of intravenous infusion of a vasopressor medication for at least one hour. 4. 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: 1. Hemophagocytic lymphohistiocytosis. 2. Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations. 3. Suspected cryptogenic organizing pneumonia presenting acutely. 4. Suspected diffuse alveolar hemorrhage. 5. Suspected acute anaphylaxis. 6. Suspected acute pulmonary drug toxicity.	1. Patient/legally authorized representative (LAR) declines participation. 2. Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for \> 48 hours. 3. Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days). 4. Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment. 5. Patient desires comfort measures only. 6. Patient is a prisoner. 7. Patient had out-of-hospital cardiac arrest leading to this hospitalization. 8. Residence immediately before this hospitalization in a long-term acute care facility. 9. Presence of tracheostomy for respiratory failure. 10. Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate). 11. Suspected cause of the patient's acute cardiovascular and/or pulmonary dysfunction (inclusion criterion #3) is an alternative condition (not ARDS, pneumonia, or sepsis), including but not limited to the list below: * Drug overdose (without aspiration, lung injury, pneumonia, or infection). * Trauma (without aspiration, pneumonia, or infection). * Chronic lung disease without suspected infection, aspiration, or inflammation. * Asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, neuromuscular respiratory failure. * Status epilepticus. * Acute pulmonary embolism. * Acute decompensated heart failure. * Diabetic ketoacidosis. * Acute stroke or intracranial hemorrhage. * Acute bleeding (GI bleeding, post-procedural bleeding, hemolysis). * Cytokine release syndrome due to chemotherapy. 12. Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years old
2. 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.")
3. 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.
* Receipt of intravenous infusion of a vasopressor medication for at least one hour.
4. 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:
1. Hemophagocytic lymphohistiocytosis.
2. Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
3. Suspected cryptogenic organizing pneumonia presenting acutely.
4. Suspected diffuse alveolar hemorrhage.
5. Suspected acute anaphylaxis.
6. Suspected acute pulmonary drug toxicity.

1. Patient/legally authorized representative (LAR) declines participation.
2. Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for \> 48 hours.
3. Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).
4. Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.
5. Patient desires comfort measures only.
6. Patient is a prisoner.
7. Patient had out-of-hospital cardiac arrest leading to this hospitalization.
8. Residence immediately before this hospitalization in a long-term acute care facility.
9. Presence of tracheostomy for respiratory failure.
10. Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate).
11. Suspected cause of the patient's acute cardiovascular and/or pulmonary dysfunction (inclusion criterion #3) is an alternative condition (not ARDS, pneumonia, or sepsis), including but not limited to the list below:
* Drug overdose (without aspiration, lung injury, pneumonia, or infection).
* Trauma (without aspiration, pneumonia, or infection).
* Chronic lung disease without suspected infection, aspiration, or inflammation.
* Asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, neuromuscular respiratory failure.
* Status epilepticus.
* Acute pulmonary embolism.
* Acute decompensated heart failure.
* Diabetic ketoacidosis.
* Acute stroke or intracranial hemorrhage.
* Acute bleeding (GI bleeding, post-procedural bleeding, hemolysis).
* Cytokine release syndrome due to chemotherapy.
12. Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

Contacts and Locations

Study Contact

Wesley H. Self, MD, MPH

CONTACT

1-615-936-8047

wesley.self@vumc.org

Jillian P. Rhoads, PhD

CONTACT

1-615-936-3773

jillian.p.rhoads.1@vumc.org

Principal Investigator

Wesley H. Self, MD, MPH

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Fresno Community Hospital and Medical Center

Fresno, California, 93721

United States

Stanford University

Palo Alto, California, 94305

United States

San Francisco General Hospital

San Francisco, California, 94110

United States

University of California, San Francisco

San Francisco, California, 94143

United States

University of Colorado, Denver

Denver, Colorado, 80045

United States

Denver Health and Hospital Authority

Denver, Colorado, 80204

United States

National Jewish Health

Denver, Colorado, 80206

United States

University of Chicago

Chicago, Illinois, 60637

United States

Johns Hopkins Univeristy

Baltimore, Maryland, 21218

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Duke University

Durham, North Carolina, 27710

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Meharry Medical College

Nashville, Tennessee, 37208

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Intermountain Medical Center

Murray, Utah, 84107

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Wesley H. Self, MD, MPH, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-07-25

Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

acute respiratory distress syndrome
sepsis
pneumonia
phenotype
endotype
critical illness

Additional Relevant MeSH Terms

ARDS
Sepsis
Pneumonia