Immune Dysregulation During Sepsis: A Natural History Cohort

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07735741
Status
Not Yet Recruiting

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Conditions

  • Sepsis
  • Sepsis-Associated Immune Dysregulation
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

Background: Sepsis is an illness that occurs when the body s immune system runs out of control. This can damage organs. Sepsis causes an estimated 1 in 5 deaths worldwide. In this natural history study, researchers want to learn more about how the immune system changes during sepsis. They hope this knowledge will help them find better ways to treat sepsis. Objective: To understand how sepsis affects the body over time. Eligibility People aged 18 years and older admitted to INOVA Fairfax Hospital in Virginia and who have sepsis. Design: Researchers will collect data from participants medical records. Participants will have blood drawn at least 5 times while they are in the hospital. Blood may be collected for up to 30 days, if they remain in the hospital that long. The blood will be taken from access lines that are already in place. Some blood draws will be optional. Participants may opt to have up to 3 tests of their heart function while they are in the hospital. Some participants may have a sample of fluid collected from their lungs. Participants will have a follow-up visit about 90 days after they join the study. This visit will be by phone call if they have left the hospital. They will fill out a questionnaire. They will answer questions about their health and how they feel. The call will last about 30 minutes....

Key Dates

First listed
Jul 30, 2026
Start date
Jan 1, 2027
Status verified
Jul 2026
Primary completion
Jan 31, 2037
Completion
Jan 31, 2037

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Participants with Sepsis
    Sepsis

Primary Outcome Measure

To investigate the contribution of neutrophils and neutrophil subsets including low density neutrophils to the dysregulated immune response that occurs during the acute phase of sepsis. [ Time Frame: 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
INOVA Fairfax HospitalFalls ChurchVirginia22042
Chris King
703-953-7837

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