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Completed

NCT Number: NCT07819708

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • For patients with septic shock, persistent hypotension requiring vasopressors to maintain mean arterial pressure above 65 millimeters of mercury and serum lactate greater than 2 millimoles per liter despite adequate fluid resuscitation.
  • Ability of the patient or legally authorized representative to provide informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: From intensive care unit admission through 28 days

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

Secondary outcomes

  1. Intensive Care Unit Length of Stay

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

    The duration of stay in the intensive care unit was recorded in days for each participant.

  2. Change in Sequential Organ Failure Assessment Score

    Time frame: At intensive care unit admission, 6 hours, and 24 hours

    The Sequential Organ Failure Assessment score was used to assess dysfunction across six organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Each organ system is scored from 0 to 4 points according to the degree of dysfunction, giving a total score ranging from 0 to 24 points. Higher scores indicate more severe organ dysfunction. Changes in the Sequential Organ Failure Assessment score during the first 24 hours were evaluated to assess progression of organ dysfunction.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Comparing the Prognostic Value of Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio Among Critically Ill Patients in Sepsis and Septic Shock

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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