Immune Dysregulation During Sepsis: A Natural History Cohort (NCT07735741) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Immune Dysregulation During Sepsis: A Natural History Cohort
United States500 participantsStarted 2027-01-01
Plain-language 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....
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 \<10 microgram/dL in patients with known coronary artery disease or active EKG changes consistent with acute ischemia
* Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \> 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 10 years
Trial details
NCT IDNCT07735741
SponsorNational Heart, Lung, and Blood Institute (NHLBI)