Immune Dysregulation During Sepsis: A Natural History Cohort

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Heart, Lung, and Blood Institute (NHLBI)

About this trial

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

Qualifiers

Age >= 18 years old

Admitted to INOVA Fairfax Hospital

Meets sepsis-3 definition of sepsis in the last 48 hours

Suspected infection

Disqualifiers

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

Neutropenia (absolute neutrophil count less than 1000 cells/microliter)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 1 trial group