SepsisNCT07089524
A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis
An observational study of Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of this study is to predict the prognostic values of Neutrophil/ Lymphocyte ratio and Lactate/Albumin ratio in the outcome of patients with sepsis and septic shock with lower respiratory tract infection, also to compare between them regarding sensitivity and specificity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2024to 1 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with lower respiratory tract infection confirmed septic patients admitted to Ain Shams University Hospitals ICU
Who may be able to join
- Adults with lower respiratory tract infection
- Confirmed septic patients (under the third international consensus definitions of sepsis and septic shock),
- Admitted to intensive care unit.
- Age (18-80) years.
- Both genders.
Who cannot join
- Age: < 18 years old, > 80 years old
- Patient refusal.
- Pregnancy.
- Malignancy.
- Pathology that could affect serum albumin concentrations prior to ICU admission as Malnutrition
- Nephrotic syndrome
- Liver Cirrhosis
- Intestinal resection surgeries
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, Abbassia, 00202
Ahmed Gamal Ahmed, M.BB.CH,M.Sc, 01141164417, ahmed_gamal@med.asu.edu.eg
About this study
Official title: A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis in Patients With Lower Respiratory Tract Infection in ICU
Aim of this study is to predict the prognostic values of Neutrophil/ Lymphocyte ratio and Lactate/Albumin ratio in the outcome of patients with sepsis and septic shock with lower respiratory tract infection, also to compare between them regarding sensitivity and specificity.
Read the detailed description
Lower respiratory tract infection (LRTI) is one of the most common infectious diseases that lead to admission of patients to ICU. It includes a wide range of respiratory infections; such as pneumonia, bronchitis, empyema and lung abscess. Furthermore, it is associated with considerable morbidity and mortality. Because delay in the ICU admission of patients with LRTI has been shown to be associated with increased mortality, it can be helpful to predict the mortality of LRTI patients in hospitals.
Sepsis is a life-threatening medical emergency induced by uncontrolled systemic inflammatory response of the host to infection. Without an early and aggressive management, sepsis can rapidly lead to organ failure, tissue hypoperfusion, and death. Bacterial infections cause most cases of sepsis, but it can also be a result of other infections; such as viral, fungal or parasitic infections. Sepsis-3 definitions for sepsis management were established in 2016 according to the Surviving Sepsis Campaign guidelines. They define sepsis as "a life-threatening organ dysfunction caused by a dysregulated host response to infection", and septic shock as "a subset of sepsis in which underling circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality".
According to Sepsis-3 criteria, sepsis and septic shock are currently diagnosed as follows: sepsis-suspected or documented infection plus SOFA (Sequential Organ Failure Assessment) score ≥2; septic shock-sepsis plus vasopressor therapy needed to maintain mean arterial pressure (MAP) ≥65 mmHg plus lactate ≥2 mmol/L (18 mg/L) despite adequate fluid resuscitation. However these diagnosis criteria, the early evaluation of sepsis severity and prognosis is still imprecise and significant research is being performed to address this issue.
The neutrophil/lymphocyte ratio (NLR) was studied in order to provide an easier way to diagnose sepsis. This ratio can be calculated both from the absolute number of neutrophils and lymphocytes, and from their relative number. The importance of this report derives from the fact that physiological stress causes an increase in the number of neutrophils and a decrease in the number of lymphocytes. Sepsis stimulates lymphocyte apoptosis, so this ratio is increased in these cases. Septic shock causes a dramatic decrease in lymphocyte count, so the NLR ratio increases significantly.
Increased lactate production is a prognostic marker of generalized hypoxia in distributive shock. Previous studies have reported that lactate levels are a dependable parameter in diagnosis, therapeutic evaluation, and prognosis in circulatory shock. Increased lactate levels are used worldwide for early diagnosis, management, and in risk stratification of patients with septic shock .
Albumin is a negative acute-phase protein, and its levels can reflect the magnitude of inflammation. In critically ill patients, the degree of hypoalbuminemia thus represents the severity of the inflammatory response. Consequently, it may be a prognostic biomarker in patients with sepsis .
Although lactate and albumin values independently predict mortality, the ratio of lactate to albumin (L/A ratio) is superior as a predictor to lactate or albumin alone. This result has been recorded in studies conducted in recent years .
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| Observational group (160 patients ) | Data collection: (upon admission to ICU) All the study subjects will be submitted to: I) Careful clinical evaluation including: * Demographics. * Comorbid conditions. * Medication usage (including intravenous fluids and vasoactive medications). * Vital signs . * Mental status (Glasgow Coma Score) * SOFA (Sequential Organ Failure Assessment) score. * Duration of antibiotics treatment. II) Laboratory Investigations including: * Complete blood picture (CBC): including Neutrophils and Lymphocytes count. * Serum albumin and serum lactate. * Prothrombin time and concentrations. * Liver function tests (LFTs), serum creatinine and urea. * Electrolytes, arterial blood gases. * Highly sensitive C -reactive protein (Hs CRP). III) Microbiological investigations: Various body fluid cultures, including sputum, blood, and urine will be obtained to identify source of sepsis. All investigations will be done at Ain Shams University, central lab unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the mortality due to sepsis with lower respiratory tract infection
Detect the mortality due to sepsis and septic shock in patients with lower respiratory tract infection in ICU
Measured: From date of randomization until the date of death during the study period ( 12-18 months)
The prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in Sepsis
predict the prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in the outcome of septic patients with lower respiratory tract infection in ICU
Measured: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
Secondary outcomes (3)
The duration of intensive care unit stay
The duration of intensive care unit stay in days from admission to ICU until discharge or death during the period of the study (12-18 months)
Measured: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
The requirement for vasoactive medications
The requirement for vasoactive medications regarding the doses in microgram per kilogram per minute and the duration in days
Measured: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
Mechanical ventilatory support and renal replacement therapy
The need of mechanical ventilatory support and the need of renal replacement therapy and its duration in days
Measured: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start11 Sep 2024
- Primary completion11 Sep 2025 (estimated)
- Study completion1 Dec 2025 (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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089524
- Sponsor's protocol ID
- FMASU MD210/2024
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis in Patients With Lower Respiratory Tract Infection in ICU
- ClinicalTrials.gov ID
- NCT07089524
- Acronym / sponsor ID
- FMASU MD210/2024
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 11 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jul 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.
Aim of this study is to predict the prognostic values of Neutrophil/ Lymphocyte ratio and Lactate/Albumin ratio in the outcome of patients with sepsis and septic shock with lower respiratory tract infection, also to compare between them regarding sensitivity and specificity.
Detailed description
Lower respiratory tract infection (LRTI) is one of the most common infectious diseases that lead to admission of patients to ICU. It includes a wide range of respiratory infections; such as pneumonia, bronchitis, empyema and lung abscess. Furthermore, it is associated with considerable morbidity and mortality. Because delay in the ICU admission of patients with LRTI has been shown to be associated with increased mortality, it can be helpful to predict the mortality of LRTI patients in hospitals.
Sepsis is a life-threatening medical emergency induced by uncontrolled systemic inflammatory response of the host to infection. Without an early and aggressive management, sepsis can rapidly lead to organ failure, tissue hypoperfusion, and death. Bacterial infections cause most cases of sepsis, but it can also be a result of other infections; such as viral, fungal or parasitic infections. Sepsis-3 definitions for sepsis management were established in 2016 according to the Surviving Sepsis Campaign guidelines. They define sepsis as "a life-threatening organ dysfunction caused by a dysregulated host response to infection", and septic shock as "a subset of sepsis in which underling circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality".
According to Sepsis-3 criteria, sepsis and septic shock are currently diagnosed as follows: sepsis-suspected or documented infection plus SOFA (Sequential Organ Failure Assessment) score ≥2; septic shock-sepsis plus vasopressor therapy needed to maintain mean arterial pressure (MAP) ≥65 mmHg plus lactate ≥2 mmol/L (18 mg/L) despite adequate fluid resuscitation. However these diagnosis criteria, the early evaluation of sepsis severity and prognosis is still imprecise and significant research is being performed to address this issue.
The neutrophil/lymphocyte ratio (NLR) was studied in order to provide an easier way to diagnose sepsis. This ratio can be calculated both from the absolute number of neutrophils and lymphocytes, and from their relative number. The importance of this report derives from the fact that physiological stress causes an increase in the number of neutrophils and a decrease in the number of lymphocytes. Sepsis stimulates lymphocyte apoptosis, so this ratio is increased in these cases. Septic shock causes a dramatic decrease in lymphocyte count, so the NLR ratio increases significantly.
Increased lactate production is a prognostic marker of generalized hypoxia in distributive shock. Previous studies have reported that lactate levels are a dependable parameter in diagnosis, therapeutic evaluation, and prognosis in circulatory shock. Increased lactate levels are used worldwide for early diagnosis, management, and in risk stratification of patients with septic shock .
Albumin is a negative acute-phase protein, and its levels can reflect the magnitude of inflammation. In critically ill patients, the degree of hypoalbuminemia thus represents the severity of the inflammatory response. Consequently, it may be a prognostic biomarker in patients with sepsis .
Although lactate and albumin values independently predict mortality, the ratio of lactate to albumin (L/A ratio) is superior as a predictor to lactate or albumin alone. This result has been recorded in studies conducted in recent years .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group (160 patients ) | – | –Data collection: (upon admission to ICU) All the study subjects will be submitted to: I) Careful clinical evaluation including: * Demographics. * Comorbid conditions. * Medication usage (including intravenous fluids and vasoactive medications). * Vital signs . * Mental status (Glasgow Coma Score) * SOFA (Sequential Organ Failure Assessment) score. * Duration of antibiotics treatment. II) Laboratory Investigations including: * Complete blood picture (CBC): including Neutrophils and Lymphocytes count. * Serum albumin and serum lactate. * Prothrombin time and concentrations. * Liver function tests (LFTs), serum creatinine and urea. * Electrolytes, arterial blood gases. * Highly sensitive C -reactive protein (Hs CRP). III) Microbiological investigations: Various body fluid cultures, including sputum, blood, and urine will be obtained to identify source of sepsis. All investigations will be done at Ain Shams University, central lab unit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with lower respiratory tract infection confirmed septic patients admitted to Ain Shams University Hospitals ICU
Key inclusion criteria (5 listed)
- Adults with lower respiratory tract infection
- Confirmed septic patients (under the third international consensus definitions of sepsis and septic shock),
- Admitted to intensive care unit.
- Age (18-80) years.
- Both genders.
Key exclusion criteria (8 listed)
- Age: < 18 years old, > 80 years old
- Patient refusal.
- Pregnancy.
- Malignancy.
- Pathology that could affect serum albumin concentrations prior to ICU admission as Malnutrition
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
Detect the mortality due to sepsis with lower respiratory tract infection
Time frame: From date of randomization until the date of death during the study period ( 12-18 months)
Detect the mortality due to sepsis and septic shock in patients with lower respiratory tract infection in ICU
The prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in Sepsis
Time frame: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
predict the prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in the outcome of septic patients with lower respiratory tract infection in ICU
3 secondary outcomes
The duration of intensive care unit stay
Time frame: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
The requirement for vasoactive medications
Time frame: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
Mechanical ventilatory support and renal replacement therapy
Time frame: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )
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 28 Jul 2025.
- 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.
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 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 5 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 28 Jul 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 Ahmed Gamal Ahmed, M.BB.CH,M.Sc (01141164417, ahmed_gamal@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the mortality due to sepsis with lower respiratory tract infection (time frame: From date of randomization until the date of death during the study period ( 12-18 months)). The study lists 2 primary outcomes in all. 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 28 Jul 2025.