Immune Dysregulation During Sepsis: A Natural History Cohort

NCT07735741 | Not Yet Recruiting

• 2 other identifiers: 10002410002410-H
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Sepsis; Septic Shock; Sepsis-Associated Immune Dysregulation

Keywords

SEPSIS

Outcome Measures

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.

  10 years

Secondary 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.

  10 years

Study Arms (1)

Participants with Sepsis

Sepsis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jeffrey R Strich, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey R Strich, M.D.

CONTACT

(301) 496-9320; jeffrey.strich@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 31, 2037
• Study Completion (Estimated): January 31, 2037
• Last Updated: July 30, 2026

Record last verified: 2026-07-27

Locations

US (1)