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

NCT07089524 | Recruiting

• 1 other identifier: FMASU MD210/2024
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  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

  From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with lower respiratory tract infection confirmed septic patients admitted to Ain Shams University Hospitals ICU

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Abbassia, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

01141164417; ahmed_gamal@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: July 28, 2025
• Study Start: September 11, 2024
• Primary Completion: September 11, 2025
• Study Completion: December 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)