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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neutrophil Activation and NETosis in Patients With Sepsis and Their Association With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07888036
- Acronym / sponsor ID
- NETosis-Sepsis-Assiut-2026
- Conditions
- Sepsis, Septic Shock
- Keywords
- Neutrophil activation, NETosis, Citrullinated histone H3, Sepsis, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study aims to evaluate neutrophil activation markers and circulating citrullinated histone H3 levels in adult patients with sepsis or septic shock.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sepsis or Septic Shock | – | –Adult patients with sepsis or septic shock undergoing assessment of neutrophil activation markers and citrullinated histone H3 levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (4 listed)
- - Known hematological malignancy
- Known chronic liver disease with significant coagulopathy
- Pre-existing hemostatic disorders
- Therapeutic anticoagulation before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Citrullinated histone H3 level
Time frame: Baseline
Mean plasma citrullinated histone H3 level measured by enzyme-linked immunosorbent assay.
4 secondary outcomes
CD66b expression
Time frame: Baseline
CD15 expression
Time frame: Baseline
Platelet count
Time frame: Baseline
Number of deaths
Time frame: At 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanan G abdel azeem, prof study chair
Clinical pathology Department, Assiut University Hospitals
Radwa H Nagib, Prof study chair
Clinical pathology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Elzahraa M Abd elradry, Ass Lec (+20 10 99696566, Fatma-mohamed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citrullinated histone H3 level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.