Not Yet RecruitingNot Applicable

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

45 participantsStarted 2026-07-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 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.

1\. Inclusion Criteria (1) Sepsis-Associated Critical Illness Cohort * Age 18-80 years, both genders; * Meets the Sepsis-3.0 criteria: confirmed or suspected infection with an acute increase in SOFA score of ≥2 points; * Admitted to the intensive care unit (ICU) for 48-72 hours at the time of enrolment; * Expected ICU length of stay ≥7 days; * Written informed consent provided by the patient or their legally authorized representative. (2) Non-Septic Critical Illness Cohort * Age 18-80 years, both genders; * Admitted to the ICU for 48-72 hours with a diagnosis of non-infectious critical illness, including but not limited to: (a) severe acute pancreatitis; (b) major trauma (Injury Severity Score ≥16); (c) post-major surgery (e.g., cardiovascular surgery, hepatectomy); (d) acute cerebrovascular disease (ischaemic stroke, intracerebral haemorrhage); (e) other critical conditions requiring ICU support; * Expected ICU length of stay ≥7 days; * Written informed consent provided by the patient or their legally authorized representative. (3) Healthy Volunteer Control Cohort * Age 18-80 years, both genders. * No acute or chronic medical history; recent health check-up results are normal. * Normal complete blood count: white blood cell count, haemoglobin, and platelet count within the normal reference ranges; * Willing and able to provide written informed consent. 2\. Exclusion Criteria (1) Sepsis-Associated Critical Illness Cohort * Haematological disorders: previous or c…

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

Percentage and Absolute Count of Hematopoietic Stem Cells (HSCs) in Bone Marrow

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

Percentage and Absolute Count of Common Myeloid Progenitors (CMPs) in Bone Marrow

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

Percentage and Absolute Count of Granulocyte-Monocyte Progenitors (GMPs) in Bone Marrow

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

Percentage and Absolute Count of Megakaryocyte-Erythroid Progenitors (MEPs) in Bone Marrow

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

Percentage and Absolute Count of Common Lymphoid Progenitors (CLPs) in Bone Marrow

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

GMP-to-CLP Ratio and Absolute Differential Count Index in Bone Marrow (Primary Composite Index)

Timeframe: Between 48 and 72 hours after enrollment (preferably day 3)

Trial details

NCT IDNCT07667153

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-15

Contact for this trial

Zhang Jiancheng, MD, PhD

+8613554105815 zhjcheng1@126.com

View on ClinicalTrials.gov More Sepsis trials