Comparing Blood-Based Ratios for Predicting Outcomes in Sepsis and Septic Shock

NCT07819708 | Completed

• 1 other identifier: MS.4.11.2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Septic Shock; Sepsis

Keywords

Neutrophil-to-lymphocyte ratio; Lactate-to-albumin ratio; 28-day mortality; Prognostic biomarker; Sequential Organ Failure Assessment

Outcome Measures

Primary Outcomes (1)

• 28-Day All-Cause Mortality

  The number and percentage of participants who died from any cause within 28 days after study enrollment.

  From intensive care unit admission through 28 days

Secondary Outcomes (2)

• Intensive Care Unit Length of Stay

  From intensive care unit admission until intensive care unit discharge or death, assessed through 28 days

• Change in Sequential Organ Failure Assessment Score

  At intensive care unit admission, 6 hours, and 24 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: October 10, 2025
• Primary Completion: September 9, 2026
• Study Completion: September 9, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

EG (1)