Neutrophils to LymphocytesNCT07200817
Neutrophils to Lymphocytes and Platelets Ratio, Procalcitonin, and Total Leucocytic Count as Indicators of Prognostic Outcome in Septic Patients in the Intensive Care Unit.
An observational study of Neutrophils to Lymphocytes and Platelets, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare Neutrophil to Lymphocyte and Platelet Ratio, Procalcitonin, and Total Leucocyte Count as indicators of prognostic outcome in septic patients in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neutrophils to Lymphocytes, Platelets, Procalcitonin
- What is being tested?
- Neutrophils to Lymphocytes and Platelets ratio (N/LP)
- How many people
- 290 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2024to 19 Mar 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective observational study will be conducted at Ain Shams University Hospital, Cairo, Egypt.
Who may be able to join
- Age from 18 to 70 years old.
- Both sexes.
- Septic patients (under the third international consensus definitions of sepsis and septic shock).
Who cannot join
- Pregnancy
- Malignancy
- On immunosuppressive therapy
- Hematological Disorders
- Major Trauma
- Major Burns
- Child-Pugh Class C Liver Cirrhosis
- On Hemodialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Michael G Farag, Master, 00201278142328, MICHAELFARAG@med.asu.edu.eg
Bassem B Ghobrial, MD
About this study
Official title: Comparison Between Neutrophils to Lymphocytes and Platelets Ratio, Procalcitonin, and Total Leucocytic Count as Indicators of Prognostic Outcome in Septic Patients in the Intensive Care Unit.
This study aims to compare Neutrophil to Lymphocyte and Platelet Ratio, Procalcitonin, and Total Leucocyte Count as indicators of prognostic outcome in septic patients in the intensive care unit.
Read the detailed description
Sepsis affects more than 30 million people annually worldwide and is one of the significant causes of death in critical patients worldwide. Any infected person can potentially develop sepsis, and the incidence of sepsis is as high as 1-2% of all hospitalized patients.
Many potential sepsis biomarkers have been proposed, procalcitonin (PCT) and C-reactive protein (CRP) being the most frequently studied.
The ratio of neutrophils to lymphocytes and platelets (N/LP) is a low-cost measure that can be obtained through routine blood tests and is often used to reflect the body's inflammatory state.
- Conditions
- Neutrophils to Lymphocytes, Platelets, Procalcitonin, Total Leucocytic Count, Prognostic Outcome, Septic Patients
- Being tested
- Neutrophils to Lymphocytes and Platelets ratio (N/LP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophils to Lymphocytes and Platelets ratio (N/LP)Diagnostic test
The Neutrophils to Lymphocytes and Platelets ratio (N/LP) will be measured
| Study group | Role | What they receive |
|---|---|---|
| Study group | Septic patients (under the third international consensus definitions of sepsis and septic shock) Receives: Diagnostic Test: Neutrophils to Lymphocytes and Platelets ratio (N/LP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Neutrophils to Lymphocytes and Platelets ratio
The ratio of neutrophils to Lymphocytes and Platelets in relation to 28-day mortality among septic patients will be recorded.
Measured: 28 days post-procedure
Secondary outcomes (2)
Procalcitonin (PCT)
Procalcitonin (PCT) in relation to 28day mortality among septic patients will be recorded.
Measured: 28 days post-procedure
Total Leukocytic Count (TLC)
Total Leukocytic Count (TLC) in relation to 28day mortality among septic patients will be recorded.
Measured: 28 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start20 Sep 2024
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutrophils to LymphocytesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAEL GAMAL SAMAAN FARAG, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200817
- Sponsor's protocol ID
- FMASU MD224/2024
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Neutrophils to Lymphocytes and Platelets Ratio, Procalcitonin, and Total Leucocytic Count as Indicators of Prognostic Outcome in Septic Patients in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07200817
- Acronym / sponsor ID
- FMASU MD224/2024
- Conditions
- Neutrophils to Lymphocytes, Platelets, Procalcitonin, Total Leucocytic Count, Prognostic Outcome, Septic Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Mar 2026 (estimated)
- First posted
- 1 Oct 2025 (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 study aims to compare Neutrophil to Lymphocyte and Platelet Ratio, Procalcitonin, and Total Leucocyte Count as indicators of prognostic outcome in septic patients in the intensive care unit.
Detailed description
Sepsis affects more than 30 million people annually worldwide and is one of the significant causes of death in critical patients worldwide. Any infected person can potentially develop sepsis, and the incidence of sepsis is as high as 1-2% of all hospitalized patients.
Many potential sepsis biomarkers have been proposed, procalcitonin (PCT) and C-reactive protein (CRP) being the most frequently studied.
The ratio of neutrophils to lymphocytes and platelets (N/LP) is a low-cost measure that can be obtained through routine blood tests and is often used to reflect the body's inflammatory state.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Neutrophils to Lymphocytes and Platelets ratio (N/LP)Septic patients (under the third international consensus definitions of sepsis and septic shock) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective observational study will be conducted at Ain Shams University Hospital, Cairo, Egypt.
Key inclusion criteria (3 listed)
- Age from 18 to 70 years old.
- Both sexes.
- Septic patients (under the third international consensus definitions of sepsis and septic shock).
Key exclusion criteria (8 listed)
- Pregnancy
- Malignancy
- On immunosuppressive therapy
- Hematological Disorders
- Major Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutrophils to Lymphocytes and Platelets ratio (N/LP)The Neutrophils to Lymphocytes and Platelets ratio (N/LP) will be measured | Diagnostic test | Study group |
Primary outcome
Levels of Neutrophils to Lymphocytes and Platelets ratio
Time frame: 28 days post-procedure
The ratio of neutrophils to Lymphocytes and Platelets in relation to 28-day mortality among septic patients will be recorded.
2 secondary outcomes
Procalcitonin (PCT)
Time frame: 28 days post-procedure
Total Leukocytic Count (TLC)
Time frame: 28 days post-procedure
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 1 Oct 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Neutrophils to Lymphocytes and Platelets, run by Ain Shams 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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?
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 Michael G Farag, Master (00201278142328, MICHAELFARAG@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Neutrophils to Lymphocytes and Platelets ratio (time frame: 28 days post-procedure). 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 1 Oct 2025.