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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Ahmed Gamal Ahmed, M.BB.CH,M.Sc contact

01141164417

ahmed_gamal@med.asu.edu.eg

Egypt1 site, 1 recruiting
  • Ain Shams university

    Cairo, Abbassia, 00202

    Ahmed Gamal Ahmed, M.BB.CH,M.Sc, 01141164417, ahmed_gamal@med.asu.edu.eg

    Recruiting

Other trials in Egypt

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 groups in NCT07089524
Study groupRoleWhat 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.

  1. 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)

  2. 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)
  1. 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 )

  2. 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 )

  3. 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.

  1. First posted28 Jul 2025
  2. Study start11 Sep 2024
  3. Primary completion11 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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)
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

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.

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