Materials and methods

This is cross-sectional research, and it was conducted at M. Islam Medical and Dental College, Gujranwala, Pakistan, from January 2025 to June 2025. The study was approved by the Institutional Ethical Review Board of M. Islam Medical and Dental College (approval 492/24, dated November 15, 2024). Informed consent was obtained in writing from all the patients to include them in this research.

The sample size was calculated using an expected prevalence of 50%, a 95% confidence level, and a 5% margin of error. A prevalence of 50% was selected because reliable local estimates of sepsis-related organ dysfunction were unavailable. This conservative assumption provides the maximum sample size required when the expected prevalence is uncertain. The calculated sample size was 384 participants [11].

Adult patients with suspected or confirmed infection were screened at hospital admission. Initial bedside assessment was performed using the quick Sequential Organ Failure Assessment (qSOFA) score, which included a respiratory rate of at least 22 breaths per minute, altered mental status, and systolic blood pressure of 100 mmHg or less [12]. Patients with a qSOFA score of at least 2 underwent further clinical and laboratory assessment. Sepsis-related organ dysfunction was assessed using the Sequential Organ Failure Assessment (SOFA) score [13].

Demographic data and clinical information, including age, gender, comorbidities, vital signs, and laboratory findings, were collected from patient interviews and hospital records using an author-developed data collection pro forma (Appendix A). Venous blood samples were obtained at admission. CBCs were performed using an automated hematology analyzer. The NLR was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. Serum creatinine was measured using a standard enzymatic method in the hospital laboratory. Sepsis-related organ dysfunction was identified based on the presence of acute organ impairment documented by the treating physician and supported by laboratory and clinical findings.

Sepsis-related organ dysfunction was defined as an acute increase of at least 2 points in the SOFA score from baseline. The SOFA score was calculated using respiratory, cardiovascular, hepatic, coagulation, neurological, and renal parameters recorded at hospital admission. In patients without known pre-existing organ dysfunction, the baseline SOFA score was assumed to be zero. This standardized definition was used instead of relying solely on the treating physician’s clinical documentation.

Data were analyzed using IBM SPSS Statistics for Windows, version 26.0 (released 2018; IBM Corp., Armonk, NY, USA). Continuous variables were presented as mean ± SD, while categorical variables were reported as frequency and percentage. Independent-samples t-test and chi-square test were used for group comparisons where appropriate. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the predictive performance of NLR and serum creatinine for early detection of sepsis-related organ dysfunction. Multivariable logistic regression analysis was used to identify independent predictors after adjustment for potential confounders. A p-value of less than 0.05 was considered statistically significant.