Phenotyping Study for Acute Respiratory Distress Syndrome

Recruiting at 19 trial locations

Overseen By Jillian P. Rhoads, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Prisoner, Long-term care, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand the risk factors, potential markers in the body, and recovery times for adults with ARDS (a severe lung condition), pneumonia, or sepsis (a severe response to infection). Participants will contribute to a collection of samples for future research on these conditions. Ideal candidates are adults admitted to intensive care with severe breathing or heart issues, such as needing extra oxygen or specific medications for low blood pressure, due to an acute inflammatory condition like pneumonia or sepsis.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better treatments for severe inflammatory conditions.

What prior data suggests that this study protocol is safe?

In this study, researchers observe individuals with ARDS (a severe lung condition), pneumonia, and sepsis to gain insights into these illnesses. The study does not introduce any new treatments or drugs, eliminating safety concerns related to new medications. Instead, researchers monitor participants over time to gather health information.

Studies of this nature are generally safe, as they focus on observation and data collection rather than testing new treatments. Previous research has shown that participating in long-term health studies does not impact participants' health or lifespan. Therefore, joining this study should not pose any additional health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the APS Phenotyping Study because it aims to provide a deeper understanding of how Antiphospholipid Syndrome (APS) manifests and progresses over time. Unlike current treatment options that primarily focus on managing symptoms through anticoagulants like warfarin or aspirin, this study investigates the diverse presentations of APS to identify specific phenotypes. By identifying these phenotypes, the study hopes to pave the way for more personalized treatment approaches that could improve patient outcomes. This could ultimately lead to treatments that are more targeted and effective than the existing one-size-fits-all methods.

Who Is on the Research Team?

Wesley H. Self, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

I have received a vasopressor medication through an IV for at least one hour.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Hospitalization and Initial Data Collection

Collection of clinical data, questionnaires, and samples such as blood, urine, stool, and respiratory samples for mechanically ventilated patients

Up to 28 days

In-hospital

Post-Hospital Follow-up

In-person study assessments at 3, 6, and 12 months post-hospitalization to evaluate long-term outcomes and collect additional data

12 months

3 visits (in-person)

Long-term Outcomes Monitoring

Monitoring of various health outcomes including neurocognitive function, physical performance, and quality of life

12 months

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12047467/

Importance of cohort and target trial emulation in clinical ... While cohort studies provide long-term and large-scale observation data, TTEs require structured data to simulate the trial. This creates an opportunity for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352827322002129

Does participating in a long-term cohort study impact ... Participating in a health-focused cohort study for half a century does not impact participants' longevity. This is true across groups defined by socioeconomic ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0246451

Systematic review and meta-analysis of cohort studies of long ... Long term exposure to NO 2 was significantly associated with mortality from all/ natural causes (pooled HR 1.047, 95% confidence interval (CI), 1.023–1.072 per ...

4. jacc.org jacc.org/doi/10.1016/j.jcin.2023.03.002

1-Year Outcomes in a Pooled Cohort of Harmony ... The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

5. journal.chestnet.org journal.chestnet.org/article/S0012-3692(20)30464-5/pdf

Cohort Studies: Design, Analysis, and Reporting In clinical research, cohort studies are appropriate when there is evidence to suggest an association between an exposure and an outcome, and the time interval.