Myeloid Bias in the Bone Marrow of Septic Patients and Its Correlation With Disease Severity and Prognosis: A Single-Center, Prospective Cohort Study

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07667153
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Bone marrow aspirate collection — PROCEDURE
    Bone marrow aspiration was performed at the posterior superior iliac spine under local anesthesia 24-48 hours after enrollment. Using a standard aspirate needle and strict aseptic technique, approximately 2-3 mL of bone marrow aspirate was collected.

Study Details

Sepsis remains a leading cause of critical illness worldwide, yet the underlying mechanisms driving its profound and persistent immune dysfunction are incompletely understood. The bone marrow, as the birthplace of all immune cells, plays a central role in orchestrating systemic immune responses. Emerging evidence from animal models suggests that sepsis triggers emergency myeloid-biased hematopoiesis in the bone marrow, characterized by expansion of myeloid progenitors and myeloid-derived suppressor cells (MDSCs) at the expense of lymphoid and erythroid lineages. This bone marrow remodeling precedes peripheral immune alterations and may represent the initiating event of sepsis-induced immunosuppression. However, direct clinical evidence in humans is scarce. This prospective, single-center cohort study aims to systematically characterize bone marrow hematopoietic remodeling in patients with septic shock, compared to critically ill non-septic patients and healthy volunteers, and to determine whether the degree of myeloid lineage bias correlates with disease severity, immunosuppression, and adverse clinical outcomes. This study will enroll three cohorts. Bone marrow aspirates and peripheral blood samples will be collected at 48-72 hours post-enrollment for flow cytometric immunophenotyping of hematopoietic stem/progenitor cells, MDSC subsets, and PD-L1 expression, as well as cytokine profiling and exploratory single-cell transcriptomics. Rectal swabs will be collected synchronously for 16S rRNA sequencing and untargeted metabolomics to investigate the association between gut microbiota, microbial metabolites, and bone marrow myeloid skewing, testing the gut-bone marrow-immune axis hypothesis. Clinical severity (SOFA/APACHE II), secondary infections, and 90-day mortality will be assessed to evaluate prognostic value. By integrating bone marrow hematopoiesis, gut microbiome, and clinical outcomes, this study seeks to provide novel mechanistic insights into sepsis-induced immunoparalysis and identify potential biomarkers or therapeutic targets for immune restoration.

Key Dates

First listed
Jun 24, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: Sepsis-Associated Critical Illness Cohort
    Patients admitted to the intensive care unit (ICU) with a confirmed or highly suspected infection and meeting the Sepsis-3 criteria (an acute change in Sequential Organ Failure Assessment \[SOFA\] score ≥ 2 points in the presence of infection).
  • Arm: Non-Septic Critical Illness Cohort
    Critically ill patients admitted to the same ICU with an acute life-threatening condition that is not attributed to infection. Typical etiologies include severe trauma, major elective or emergency surgery (e.g., abdominal, or neurosurgical procedures), acute pancreatitis, or massive haemorrhage, all without any clinical or microbiological evidence of infection at enrolment.
  • Arm: Healthy Volunteer Control Cohort
    Community-dwelling adults with no acute or chronic medical conditions that could affect haematopoiesis or immune function. They are recruited from the same geographical region and during the same calendar period to minimise seasonal and demographic biases.

Primary Outcome Measure

Percentage and Absolute Count of Hematopoietic Stem Cells (HSCs) in Bone Marrow [ Time Frame: Between 48 and 72 hours after enrollment (preferably day 3) ]

Central Contacts

Related Studies