Glucose and Lymphocyte Ratio as a Prognostic Marker In Patients of Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- 1.Mortality rate 28-day in-hospital mortality.
研究概览
简要总结
Evaluation of Glucose-Lymphocyte Ratio as a Prognostic Marker in Patients with Sepsis Admitted in AVBRH
IntroductionSepsis 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:
- To estimate glucose levels in all sepsis patients.
- To estimate lymphocyte counts in all sepsis patients.
- To correlate GLR with mortality, hospital stay duration, and need for mechanical ventilation in sepsis.
- 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:
- Blood Sample Collection for CBC:
- Venipuncture with antiseptic precautions
- Blood collected in EDTA bulbs for immediate analysis
- Calculation of Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR):
- Blood sample processed using a centrifuge at 900 rpm for 15 minutes
- Blood Sample Collection for KFT and LFT:
- Blood collected in red plain bulbs for biochemical analysis
- Arterial Blood Gas (ABG) Collection:
- Radial artery puncture with antiseptic technique
- Immediate heparinization of the syringe
- 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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients diagnosed with sepsis: Only individuals who meet the clinical criteria for sepsis (e.g., infection with systemic inflammatory response) should be included in the study.
- •2.Adults aged 18 years and above: Include adult patients, as the study may focus on how glucose and lymphocyte ratios impact prognosis in the adult population.
- •3.Availability of relevant laboratory data: Participants should have recent blood tests, including glucose levels and lymphocyte counts, available for analysis to calculate the glucose and lymphocyte ratio.
排除标准
- •1.Diabetic patients Pre-existing diabetes alters glucose levels affecting study outcomes.
- •2.Immunosuppressed patients – Those on chemotherapy, steroids, or immunosuppressants may have skewed lymphocyte ratios.
- •3.Hematologic or autoimmune disorders Conditions like leukemia or lupus impact lymphocyte counts introducing bias.
结局指标
主要结局
1.Mortality rate 28-day in-hospital mortality.
时间窗: 1.Mortality rate 28-day in-hospital mortality. | 2.ICU length of stay – Duration of ICU admission. | 3.Organ dysfunction progression – Evaluated using SOFA score changes.
2.ICU length of stay – Duration of ICU admission.
时间窗: 1.Mortality rate 28-day in-hospital mortality. | 2.ICU length of stay – Duration of ICU admission. | 3.Organ dysfunction progression – Evaluated using SOFA score changes.
3.Organ dysfunction progression – Evaluated using SOFA score changes.
时间窗: 1.Mortality rate 28-day in-hospital mortality. | 2.ICU length of stay – Duration of ICU admission. | 3.Organ dysfunction progression – Evaluated using SOFA score changes.
次要结局
- 1.Need for mechanical ventilation – Incidence and duration of ventilatory support.
研究者
Dr Tushar Rajesh Sontakke
Datta Meghe Institute of Higher education and Research
