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NCT07735741
Immune Dysregulation During Sepsis: A Natural History Cohort
Conditions: Sepsis, Septic Shock, Sepsis-Associated Immune Dysregulation
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Location: INOVA Fairfax Hospital Falls Church Virginia
Summary
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....
Eligibility Criteria
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Age \>= 18 years old
* Admitted to INOVA Fairfax Hospital
* Meets sepsis-3 definition of sepsis in the last 48 hours
* Suspected infection
* Evidence of organ dysfunction (SOFA score \>= 2)
* Ability of subject or LAR to understand and the willingness to sign a written informed consent document
EXCLUSION CRITERIA:
Any individual who meets any of the following criteria will be excluded from participation in this study:
* Hemoglobin \< 7 microgram/dL at the time of enrollment
* Hemoglobin \ 2.5
microgram/kg/min, norepinephrine of \> 20 mircogram/min, or vasopressin \> 0.04 units/min
* Neutropenia (absolute neutrophil count less than 1000 cells/microliter)
* Baseline cognitive impairment
* Pregnancy
Source: ClinicalTrials.gov (NCT07735741). StuddyBuddy aggregates publicly available trial information.