1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [DRJASWANTHVARMAALLURI@GMAIL.COM].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Evaluation of Glucose-Lymphocyte Ratio as a Prognostic Marker in Patients with Sepsis Admitted in AVBRH

Introduction

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is a severe subset of sepsis characterized by circulatory, cellular, and metabolic abnormalities contributing to an increased risk of mortality [1].

The Global Burden of Disease study estimated that in 2017, there were 48.9 million sepsis cases worldwide, leading to 11.0 million sepsis-related deaths (19.7% of all global deaths). In India alone, 11.3 million cases of sepsis and 2.9 million deaths (297.7 per 100,000 population) were reported. This highlights the importance of sepsis prevention, diagnosis, and treatment in countries like India.

Sepsis is recognized as a host-mediated systemic inflammatory response to infection, with dysregulated immune cell activation playing a critical role in severe sepsis [2]. Several systemic inflammatory biomarkers, including neutrophil-lymphocyte ratio (NLR) [3], platelet-lymphocyte ratio (PLR) [4], lymphocyte-monocyte ratio (LMR) [5], and red cell distribution width (RDW) [6], have been associated with sepsis prognosis.

Lymphocytes are essential immune effector cells in sepsis, and extensive lymphocyte apoptosis contributes to the immunosuppressive phase of sepsis [7]. A decrease in lymphocyte count has been associated with poor prognosis in septic patients [8].

Acute hyperglycemia is an independent risk factor for in-hospital mortality in critically ill sepsis patients [9]. Failure to control hyperglycemia has been linked to adverse outcomes such as increased mortality, nosocomial infections, prolonged ICU stay, and complications like neuropathy. The imbalance between glucose levels and lymphocyte counts is reflected in the glucose-to-lymphocyte ratio (GLR) [10].

Increased GLR indicates an imbalance in glucose regulation and immune responses, potentially leading to organ failure, metabolic derangements, immune deficiencies, and mortality [11]. Recent evidence suggests a strong association between elevated glucose levels, decreased lymphocyte counts, and sepsis severity [12].

This study aims to evaluate the relationship between GLR and hospital outcomes in sepsis patients. By including both glucose levels and systemic inflammation markers, GLR may provide a novel prognostic tool for clinical sepsis management [13].

AIM AND OBJECTIVES

Aim:

To evaluate the efficacy of the glucose-lymphocyte ratio (GLR) as a prognostic marker in sepsis patients admitted to AVBRH.

Objectives:

1. To estimate glucose levels in all sepsis patients.

2. To estimate lymphocyte counts in all sepsis patients.

3. To correlate GLR with mortality, hospital stay duration, and need for mechanical ventilation in sepsis.

4. To compare the prognostic value of GLR with the APACHE-IV score in sepsis.

Materials and Methods

Study Design:

• Type: Prospective, Cross-sectional study

• Study Area: Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi (Meghe)

• Duration: 2023–2026

• Sample Size: 115 (Calculated using Krejcie and Morgan Formula)

• Study Population: Patients admitted to MICU at AVBRH with sepsis

Inclusion Criteria:

• Consenting patients

• Patients diagnosed with sepsis based on qSOFA scores

Exclusion Criteria:

• Non-consenting patients

• Patients on anti-platelet treatment

• Pregnant patients

• Patients who expire within 24 hours of admission

Investigations Required:

• Complete Blood Count (CBC) – HB, WBC, Neutrophils, Lymphocytes, Platelets

• Kidney Function Test (KFT) – Urea, Creatinine, Sodium, Potassium

• Random Blood Sugar (RBS)

Equipment and Procedures:

1. Blood Sample Collection for CBC:

   • Venipuncture with antiseptic precautions

   • Blood collected in EDTA bulbs for immediate analysis

2. Calculation of Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR):

   • Blood sample processed using a centrifuge at 900 rpm for 15 minutes

3. Blood Sample Collection for KFT and LFT:

   • Blood collected in red plain bulbs for biochemical analysis

4. Arterial Blood Gas (ABG) Collection:

   • Radial artery puncture with antiseptic technique

   • Immediate heparinization of the syringe

5. GLR Calculation:

   • Formula: GLR = Glucose Count / Lymphocyte Count

Clinical Assessments:

• Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR), and Glasgow Coma Scale (GCS)

• Medical history documentation (Hypertension, Diabetes Mellitus, chronic illnesses, smoking/alcohol history)

Scoring Systems Used:

qSOFA Score:

• Systolic BP < 100 mmHg – 1 point

• Respiratory rate > 22/min – 1 point

• Altered mental status – 1 point

• qSOFA score > 2 indicates sepsis

APACHE IV Score:

• Includes physiological and chronic health condition parameters to predict mortality risk

Statistical Analysis

• Continuous variables: Expressed as Mean ± Standard Deviation, compared using unpaired t-test or ANOVA.

• Categorical variables: Expressed as frequencies and percentages, analyzed using chi-square tests.

• Correlation analysis: Performed using Pearson’s or Spearman’s correlation coefficients.

• Statistical software: SPSS version 27.0

• Significance level: p < 0.05 considered statistically significant.

Ethical Considerations

• Informed Consent: Patients will be informed about study procedures in their native language. Written consent will be obtained.

• Confidentiality: Patient data will be anonymized and stored securely in a password-protected database.

• Adherence to Guidelines: The study follows institutional ethical committee guidelines and Good Clinical Practice (GCP) standards.