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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of up to 500 adults admitted to INOVA Fairfax Hospital with community-onset or hospital-onset sepsis. Eligible participants must be 18 years of age or older, meet the Sepsis-3 definition of sepsis within the last 48 hours, have suspected infection, and show evidence of organ dysfunction (SOFA score \>=2). Participants are enrolled during inpatient hospitalization and followed longitudinally for up to 90 days from enrollment or until hospital discharge if hospitalization lasts longer than 90 days.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Participants with Sepsis
Trial outcomes
Primary outcomes
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.
The primary outcomes is intended to study how certain immune cells contribute to sepsis pathogenesis.
Time frame
10 yearsSecondary outcomes
1
To characterize spleen tyrosine kinase expression across immune cells and correlate with soluble biomarkers, cellular phenotypes and gene expression to determine mechanistic pathways that may be amenable to host-direct therapies.
The secondary outcomes are to study specific immune targets that may be developed into treatments for sepsis.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: