Bone marrow secrets may unlock sepsis recovery
NCT ID NCT07667153
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how sepsis affects the bone marrow, where immune cells are made. Researchers will compare bone marrow samples from 45 people: those with sepsis, other critically ill patients, and healthy volunteers. The goal is to understand why sepsis can weaken the immune system and find new ways to help patients fight infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could point toward new ways to restore immune function in sepsis patients by targeting bone marrow changes.
- What could go wrong
- This is an early observational study with only 45 participants. It aims to understand the disease, not test a treatment, so direct patient benefits are not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This prospective single-centre study will enrol three independent cohorts: (1) adult ICU patients (18-80 years) with sepsis per Sepsis-3.0, admitted for 48-72 hours with an expected ICU stay ≥7 days; (2) adult ICU patients with non-infectious critical illnesses (e.g., severe pancreatitis, major trauma, post-major surgery, acute cerebrovascular events) who do not meet Sepsis-3.0 criteria; and (3) healthy community volunteers with no acute/chronic diseases and normal blood counts. All participants (or legally authorised representatives for incapacitated patients) must provide written informed consent, with re-consent obtained once patients regain capacity. Common exclusions include primary haematological disorders, active malignancy, immunosuppression, recent transfusion, severe chronic organ dysfunction, local contraindications to bone marrow puncture, pregnancy, and concurrent participation in other interventional trials.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 current primary haematological diseases affecting bone marrow haematopoiesis, including leukaemia, myelodysplastic syndromes, aplastic anaemia, multiple myeloma, lymphoma, etc; * Active malignancy or receipt of chemotherapy/radiotherapy within the past 3 years; * Immunosuppressed state: (a) use of immunosuppressive agents within the past 3 months (including glucocorticoids ≥0.5 mg/kg/day for ≥2 weeks); (b) history of solid organ or haematopoietic stem cell transplantation; (c) HIV infection or AIDS; (d) congenital immunodeficiency; * Blood transfusion or bone marrow transplantation within the past 3 months; * Severe chronic organ dysfunction: (a) Child-Pugh Class C liver disease; (b) end-stage renal disease (eGFR \<30 mL/min) without regular dialysis; * Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine; * Pregnancy or breastfeeding; * Moribund state with expected survival \<24 hours; * Participation in another interventional clinical trial within 3 months before or at enrolment; * Refusal to sign informed consent by the patient or legal representative. (2) Non-Septic Critical Illness Cohort * Evidence of infection: confirmed or suspected active infection (including pneumonia, intra-abdominal infection, urinary tract infection, bloodstream infection, etc.) within 48 hours of ICU admission; * All other exclusion criteria listed for the Sepsis-Associated Critical Illness Cohort (items 1-10) apply. (3) Healthy Volunteer Control Cohort * History of infection within the past 1 month; * Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine; * Pregnancy or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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