SepsisNCT07888036
Neutrophil Activation and NETosis in Sepsis
An observational study of Sepsis and Septic Shock, run by Assiut University.
Trial summary
This prospective observational study aims to evaluate neutrophil activation markers and circulating citrullinated histone H3 levels in adult patients with sepsis or septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 1 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years or older with sepsis or septic shock enrolled within 24 hours of diagnosis or admission to the intensive care unit at Assiut University Hospital.
Who may be able to join
- - Adults aged 18 years or older
- Patients fulfilling sepsis or septic shock criteria
- Enrollment within 24 hours of diagnosis or ICU admission
- Written informed consent
Who cannot join
- - Known hematological malignancy
- Known chronic liver disease with significant coagulopathy
- Pre-existing hemostatic disorders
- Therapeutic anticoagulation before enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Neutrophil Activation and NETosis in Patients With Sepsis and Their Association With Clinical Outcomes
This prospective observational study aims to evaluate neutrophil activation markers and circulating citrullinated histone H3 levels in adult patients with sepsis or septic shock.
Read the detailed description
Sepsis is a life-threatening syndrome caused by a dysregulated host response to infection. Neutrophils play a central role through activation and release of neutrophil extracellular traps (NETs).
This observational study will assess neutrophil surface activation markers by flow cytometry and circulating citrullinated histone H3 levels by ELISA in adult patients with sepsis or septic shock enrolled within 24 hours of diagnosis, with measurements on the first and third day.
- Conditions
- Sepsis, Septic Shock
- Keywords
- Neutrophil activation, NETosis, Citrullinated histone H3, Sepsis, Assiut
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sepsis or Septic Shock | Adult patients with sepsis or septic shock undergoing assessment of neutrophil activation markers and citrullinated histone H3 levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrullinated histone H3 level
Mean plasma citrullinated histone H3 level measured by enzyme-linked immunosorbent assay.
Measured: Baseline
Secondary outcomes (4)
CD66b expression
Mean percentage of neutrophils expressing CD66b measured by flow cytometry.
Measured: Baseline
CD15 expression
Mean percentage of neutrophils expressing CD15 measured by flow cytometry.
Measured: Baseline
Platelet count
Mean platelet count.
Measured: Baseline
Number of deaths
Number of patients who die within 28 days.
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elzahraa Mohamed Abd Elrady Farghly, Assiut University
- Investigators
- Hanan G abdel azeem, prof, Study chair, Clinical pathology Department, Assiut University HospitalsRadwa H Nagib, Prof, Study chair, Clinical pathology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888036
- Sponsor's protocol ID
- NETosis-Sepsis-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No