SepsisNCT07819708
Comparing Blood-Based Ratios for Predicting Outcomes in Sepsis and Septic Shock
An observational study of Sepsis and Septic Shock, run by Benha University at 1 site in Egypt.
Trial summary
Sepsis and septic shock are serious conditions associated with a high risk of organ dysfunction and death. Simple laboratory-based markers may help identify critically ill patients who are at greater risk of poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 9 Sep 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients aged 18 to 60 years with clinically confirmed sepsis or septic shock who were admitted to the Surgical Intensive Care Unit at Benha University Hospital and met the predefined study eligibility criteria. Participants underwent clinical and laboratory assessment and were followed for 28 days to evaluate mortality, intensive care unit length of stay, and progression of organ dysfunction.
Who may be able to join
- Adults aged 18 to 60 years with clinically confirmed sepsis or septic shock.
- Male and female patients.
- Fulfillment of at least two quick Sequential Organ Failure Assessment criteria, including:
- Glasgow Coma Scale score less than 15.
- Systolic blood pressure less than 100 millimeters of mercury.
- Respiratory rate greater than 22 breaths per minute.
Show all 17Show fewer
- Evidence of infection-related organ dysfunction demonstrated by an increase of more than 2 points in the Sequential Organ Failure Assessment score.
- Evidence of organ dysfunction, including one or more of the following:
- Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen less than 300.
- Glasgow Coma Scale score less than 15.
- Mean arterial pressure less than 70 millimeters of mercury.
- Serum creatinine greater than 1.2 milligrams per deciliter.
- Urine output less than 0.5 milliliters per kilogram per hour.
- Serum bilirubin greater than 1.2 milligrams per deciliter.
- Platelet count less than 150,000 per microliter.
- For patients with septic shock, persistent hypotension requiring vasopressors to maintain mean arterial pressure above 65 millimeters of mercury and serum lactate greater than 2 millimoles per liter despite adequate fluid resuscitation.
- Ability of the patient or legally authorized representative to provide informed consent.
Who cannot join
- Active malignancy or chemotherapy within the previous 3 months.
- Corticosteroid therapy within 90 days before admission.
- Documented severe liver or kidney dysfunction.
- Clinical conditions requiring albumin administration.
- Pregnancy or breastfeeding.
- Insufficient laboratory data or inability to complete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Prognostic Value of Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio Among Critically Ill Patients in Sepsis and Septic Shock
Sepsis and septic shock are serious conditions associated with a high risk of organ dysfunction and death. Simple laboratory-based markers may help identify critically ill patients who are at greater risk of poor outcomes.
This prospective observational cohort study compared the prognostic value of the neutrophil-to-lymphocyte ratio and the lactate-to-albumin ratio in adult patients with sepsis or septic shock admitted to the Surgical Intensive Care Unit at Benha University Hospital.
A total of 60 participants were enrolled and followed for 28 days. The study evaluated the relationship of both laboratory ratios with 28-day mortality and compared their ability to predict mortality. Intensive care unit length of stay and progression of organ dysfunction were also assessed.
- Conditions
- Sepsis, Septic Shock
- Keywords
- Neutrophil-to-lymphocyte ratio, Lactate-to-albumin ratio, 28-day mortality, Prognostic biomarker, Sequential Organ Failure Assessment
- 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 |
|---|---|---|
| Sepsis and Septic Shock Cohort | Adult patients with sepsis or septic shock admitted to the Surgical Intensive Care Unit at Benha University Hospital. Participants underwent clinical and laboratory assessment, including measurement of the neutrophil-to-lymphocyte ratio and lactate-to-albumin ratio, and were followed for 28 days to assess mortality, intensive care unit length of stay, and progression of organ dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-Cause Mortality
The number and percentage of participants who died from any cause within 28 days after study enrollment.
Measured: From intensive care unit admission through 28 days
Secondary outcomes (2)
Intensive Care Unit Length of Stay
The duration of stay in the intensive care unit was recorded in days for each participant.
Measured: From intensive care unit admission until intensive care unit discharge or death, assessed through 28 days
Change in Sequential Organ Failure Assessment Score
The Sequential Organ Failure Assessment score was used to assess dysfunction across six organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Each organ system is scored from 0 to 4 points according to the degree of dysfunction, giving a total score ranging from 0 to 24 points. Higher scores indicate more severe organ dysfunction. Changes in the Sequential Organ Failure Assessment score during the first 24 hours were evaluated to assess progression of organ dysfunction.
Measured: At intensive care unit admission, 6 hours, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start10 Oct 2025
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
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 Benha 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Elhamy Labib El-Sayed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819708
- Sponsor's protocol ID
- MS.4.11.2025
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Prognostic Value of Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio Among Critically Ill Patients in Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT07819708
- Acronym / sponsor ID
- MS.4.11.2025
- Conditions
- Sepsis, Septic Shock
- Keywords
- Neutrophil-to-lymphocyte ratio, Lactate-to-albumin ratio, 28-day mortality, Prognostic biomarker, Sequential Organ Failure Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 15 Sep 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.
Sepsis and septic shock are serious conditions associated with a high risk of organ dysfunction and death. Simple laboratory-based markers may help identify critically ill patients who are at greater risk of poor outcomes.
This prospective observational cohort study compared the prognostic value of the neutrophil-to-lymphocyte ratio and the lactate-to-albumin ratio in adult patients with sepsis or septic shock admitted to the Surgical Intensive Care Unit at Benha University Hospital.
A total of 60 participants were enrolled and followed for 28 days. The study evaluated the relationship of both laboratory ratios with 28-day mortality and compared their ability to predict mortality. Intensive care unit length of stay and progression of organ dysfunction were also assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis and Septic Shock Cohort | – | –Adult patients with sepsis or septic shock admitted to the Surgical Intensive Care Unit at Benha University Hospital. Participants underwent clinical and laboratory assessment, including measurement of the neutrophil-to-lymphocyte ratio and lactate-to-albumin ratio, and were followed for 28 days to assess mortality, intensive care unit length of stay, and progression of organ dysfunction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients aged 18 to 60 years with clinically confirmed sepsis or septic shock who were admitted to the Surgical Intensive Care Unit at Benha University Hospital and met the predefined study eligibility criteria. Participants underwent clinical and laboratory assessment and were followed for 28 days to evaluate mortality, intensive care unit length of stay, and progression of organ dysfunction.
Key inclusion criteria (17 listed)
- Adults aged 18 to 60 years with clinically confirmed sepsis or septic shock.
- Male and female patients.
- Fulfillment of at least two quick Sequential Organ Failure Assessment criteria, including:
- Glasgow Coma Scale score less than 15.
- Systolic blood pressure less than 100 millimeters of mercury.
Key exclusion criteria (6 listed)
- Active malignancy or chemotherapy within the previous 3 months.
- Corticosteroid therapy within 90 days before admission.
- Documented severe liver or kidney dysfunction.
- Clinical conditions requiring albumin administration.
- Pregnancy or breastfeeding.
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
28-Day All-Cause Mortality
Time frame: From intensive care unit admission through 28 days
The number and percentage of participants who died from any cause within 28 days after study enrollment.
2 secondary outcomes
Intensive Care Unit Length of Stay
Time frame: From intensive care unit admission until intensive care unit discharge or death, assessed through 28 days
Change in Sequential Organ Failure Assessment Score
Time frame: At intensive care unit admission, 6 hours, and 24 hours
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 15 Sep 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 and Septic Shock, run by Benha 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 17 inclusion and 6 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 15 Sep 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?
28-Day All-Cause Mortality (time frame: From intensive care unit admission through 28 days). 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 15 Sep 2026.