SepsisNCT06612307
Sensitivity and Specificity of Leucocytes Profiling Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial
An observational study of Sepsis, run by Minia University at 1 site in Egypt.
Trial summary
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- How many people
- 422 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2024to 20 Sep 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points
Who may be able to join
- Adult population of both sex, aged 20 or older admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points
Who cannot join
- Patient refusal.
- History of surgery in the last 7 days from admission.
- Immunocompromised population ( post-transplantation, steroid use > 5 mg per day, malignancy, HIV, on chemotherapy).
- History of platelet transfusion one week before admission.
- Bone marrow transplanted population on steroid therapy.
- Von-Willebrand disease.
Show all 9Show fewer
- Myelodysplastic or proliferative patients.
- Blood dyscarsiasis
- Obestetric parturients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration
SOFA increase 2 points or more, or development of septic shock, or mortality. leukocyte profile versus platelet indices. Early deterioration was defined as any of the above mentioned events occurring for the first time from T0 until (through) second calendar day. T0 was the biomarker sampling immediately after sepsis diagnosis. Timing of deterioration was subclassified from To to second calendar day ( any deterioration events for the first time from T0 until second calendar day after that defined as very early deterioration) or early deterioration ( from third calendar day to day-5 = any deterioration events occur for the first time only from third to the fifth calendar day inclusive after T0
Measured: from biomarker sampling through fifth calendar day
Secondary outcomes (6)
association between leucocytes at enrollment with ICU mortality
Measured: 2 weeks ( during ICU admission)
association between platelet indices at enrollment with ICU mortality
Measured: 2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of mechanical ventilation
Measured: 2 weeks
association between leucocytes at enrollment with incidence of mechanical ventilation
Measured: 2 weeks (during ICU admission)
association between leucocytes at enrollment , with incidence of acute kidney injury
Measured: 2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of acute kidney injury
Measured: 2 weeks (during ICU admission )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start25 Sep 2024
- Primary completion15 Sep 2025
- Study completion20 Sep 2025
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 Minia 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
- 422 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612307
- Sponsor's protocol ID
- Anet 19-2/ 04-2024-300523
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial
- ClinicalTrials.gov ID
- NCT06612307
- Acronym / sponsor ID
- Anet 19-2/ 04-2024-300523
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 25 Sep 2024 (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.
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points
Key inclusion criteria (1 listed)
- Adult population of both sex, aged 20 or older admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points
Key exclusion criteria (9 listed)
- Patient refusal.
- History of surgery in the last 7 days from admission.
- Immunocompromised population ( post-transplantation, steroid use > 5 mg per day, malignancy, HIV, on chemotherapy).
- History of platelet transfusion one week before admission.
- Bone marrow transplanted population on steroid therapy.
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
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration
Time frame: from biomarker sampling through fifth calendar day
SOFA increase 2 points or more, or development of septic shock, or mortality. leukocyte profile versus platelet indices. Early deterioration was defined as any of the above mentioned events occurring for the first time from T0 until (through) second calendar day. T0 was the biomarker sampling immediately after sepsis diagnosis. Timing of deterioration was subclassified from To to second calendar day ( any deterioration events for the first time from T0 until second calendar day after that defined as very early deterioration) or early deterioration ( from third calendar day to day-5 = any deterioration events occur for the first time only from third to the fifth calendar day inclusive after T0
6 secondary outcomes
association between leucocytes at enrollment with ICU mortality
Time frame: 2 weeks ( during ICU admission)
association between platelet indices at enrollment with ICU mortality
Time frame: 2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of mechanical ventilation
Time frame: 2 weeks
association between leucocytes at enrollment with incidence of mechanical ventilation
Time frame: 2 weeks (during ICU admission)
association between leucocytes at enrollment , with incidence of acute kidney injury
Time frame: 2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of acute kidney injury
Time frame: 2 weeks (during ICU admission )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Minia University at 1 site in Egypt.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration (time frame: from biomarker sampling through fifth calendar day). 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 9 Jul 2026.