The APS Phenotyping Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About 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.

Eligibility criteria

Qualifiers

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.")

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.

Disqualifiers

Patient/legally authorized representative (LAR) declines participation.

Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for > 48 hours.

Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).

Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.

Trial design

Treatments tested in this trial

  • Blood collection
  • Urine Collection
  • Nasal, oral, and rectal swabs
  • Stool collection
  • Heat Moisture Exchange Filter collection
  • Tracheal Aspirate sample collection
  • Non-bronchoscopic bronchoalveolar lavage (NBBAL)
  • Surveys
  • Short physical performance battery
  • Hand grip strength
  • CNS Vital Signs
  • Muscle Ultrasound
  • Muscle Strength
  • Spirometry
  • Lung Diffusion Testing (DLCO)
  • Chest CT Scan

Treatment groups

4,000 Participants
are divided into 3 treatment groups