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NCT Number: NCT06847477

SOFA Score with Serum Procalcitonin Versus SOFA Score with Neutrophil/lymphocyte Ratio in Predicting Sepsis and Clinical Outcomes in I.C.U.

Sepsis remains a critical life-threatening and a healthcare challenge worldwide. Sepsis is implicated in a mortality rate that ranges between 25 - 30% in severe cases and 40-70% in septic shock, also, Post sepsis, lower quality of life was observed among survivors, therefore early prediction and a rapid therapeutic decision, are essential to improve patient outcomes.

Different indicators are proposed as predictors but with different sensitivity, specificity, and availability. This study aims to evaluate the efficacy of PCT and SOFA scores versus SOFA and NLR in predicting morbidity and mortality outcomes in sepsis.

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Key information

About this study

Sepsis provokes a dysregulated host response to infection that leads to acute organ dysfunction. The subsequent Septic shock, which includes an underlying circulatory and cellular imbalance increases the mortality. Septic shock manifests as persistent hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) in the absence of hypovolemia.

Sequential Organ Failure Assessment score (SOFA) has become extensively used and one of the gold standard tests in assessing the patient's status during intensive care unit (ICU) stay and predicting the clinical outcomes of the patients, however, poor sensitivity of SOFA score is a major limitation that excludes its use as a screening tool for early sepsis, the stage in which treatment is most effective. Blood culture is a well-established diagnostic test for sepsis, however, has limitations e.g. prolonged incubation time and probability of false-negative results.

Procalcitonin (PCL) has been studied as a sepsis biomarker, to help with sepsis diagnosis and to guide the initiation and cessation of antibiotics. Procalcitonin strongly correlates with the extent and severity of bacterial infections, better indicator of illness severity than CRP, and also, provides a quick result compared to blood cultures. Procalcitonin use may be hindered by availability and the cost in a limited resources environment, However, The neutrophil-to-lymphocyte ratio (NLR) is a readily available marker. The neutrophil-to-lymphocyte ratio (NLR) is an indicator of systemic inflammation based on complete blood count values. In general, blood neutrophil count increases with the progress of the inflammatory disease, NLR is more reliable when predicting patient survival than either neutrophil count or lymphocyte count alone.

Endogenous cortisol and catecholamines increase the neutrophil count while simultaneously decreasing the lymphocyte count so it may be major drivers of the NLR. Also, cytokines and other hormones are likely to be involved. So NLR is not solely an indication of infection or inflammation. Any cause of physiologic stress may increase the NLR (e.g. hypovolemic shock). NLR increases rapidly following acute physiologic stress (<6 hours). This prompt response time may make NLR a better reflection of acute stress. Interpretation of NLR level is as follows: A normal NLR is roughly 1-3, An NLR of 6-9 suggests mild stress and Critically ill patients will often have an NLR of ~9 or higher (occasionally reaching values close to 100).

This research will test the predictability of combined SOFA score and procalcitonin versus combined SOFA score and NLR for clinical outcomes such as length of ICU stay and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • critically ill patients admitted to ICU for surgical or trauma causes.

Exclusion criteria

  • Lack of consent

Treatment and study plan

Primary outcomes

  1. Length of ICU stay

    Time frame: from the time of admission to the time of discharge from the ICU or death up to 40 days from ICU admission

    It includes the total number of days spent in the ICU, calculated from the time of admission to the time of discharge from the ICU or death, whichever comes first.

    The unit of measurement is days.

Secondary outcomes

  1. 28 days mortality

    Time frame: From the day of admission at the ICU and up to 28 days.

    the occurrence of the event of mortality. It will be followed from the day of admission at the ICU and up to 28 days

  2. Antibiotics used

    Time frame: From ICU admission to discharge from ICU or death which comes first up to 40 days from admission.

    Duration and number of antibiotic usage: measured by the time of the first dose of antibiotics till the time of the last dose administration in the ICU.

Study contacts

Contact information is provided by the study sponsor or research team.

Basma sherif Fahmy, MD

CONTACT

[email protected]

0021113151814

wessam zaher selima, MD

CONTACT

[email protected]

0021001958858

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

SOFA Score with Serum Procalcitonin Versus SOFA Score with Neutrophil/lymphocyte Ratio in Predicting Sepsis and Clinical Outcomes in Intensive Care Unit.

Acronym: SOFA-PROVSNL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

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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