A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis

Recruiting

• Conditions: Sepsis

• Registration Number: NCT07089524
• Lead Sponsor: Ain Shams University

Brief 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.

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 Timeline

• Study Start: 2024-09-11
• Status Verified: 2025-01
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2025-09-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detect the mortality due to sepsis with lower respiratory tract infection	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	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

Secondary Outcome Measures

Name	Time	Method
The duration of intensive care unit stay	From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )	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)
The requirement for vasoactive medications	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 regarding the doses in microgram per kilogram per minute and the duration in days
Mechanical ventilatory support and renal replacement therapy	From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )	The need of mechanical ventilatory support and the need of renal replacement therapy and its duration in days

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Abbassia, Egypt