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Long-term Outcomes Cohort for Acute Respiratory Distress Syndrome

N/A
Recruiting
Led By Wesley H. Self, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months
Awards & highlights

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.

Eligible Conditions
  • Acute Respiratory Distress Syndrome
  • Sepsis
  • Pneumonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ARDS, pneumonia, and sepsis classification
Secondary study objectives
Death
Other study objectives
Acute kidney injury (AKI)
Central Nervous System (CNS) vital signs score
Clinical frailty scale
+25 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Long-term Outcomes CohortExperimental Treatment11 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 Treatment6 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 Treatment8 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.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
930,934 Total Patients Enrolled
Wesley H. Self, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
14,889 Total Patients Enrolled
~2667 spots leftby Apr 2028
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