N\L Ratio Versus L\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock

Study Overview
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Brief Summary
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The aim of the study is to compare between neutrophil lymphocyte ratio and lactate albumin ratio as a predictor of morbidity and mortality in sepsis and septic shock patients.

Detailed Description
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Sepsis is a systemic inflammatory response syndrome caused by infection can lead to life threatening multi-organ dysfunction. Septic shock causes circulatory and metabolic abnormalities, leading to increased mortality in hospitalized patients, especially in intensive care unit (ICU) patients. Sepsis can affect the function and number of immune cells, including neutrophils, lymphocytes and monocytes. Neutrophils play crucial roles in the innate cellular immune system. Early higher neutrophil counts correlated with increased sepsis severity. In sepsis, lymphocytes decrease owing to the apoptosis mediated by innate response. Reversily, number of neutrophils dramatically increase reflecting degree of inflammation. The neutrophil-to-lymphocyte ratio (NLR) is a novel inflammatory biomarker that can be obtained through blood routine tests, it is cost- effective and widely available, and it is beneficial to the early recognition of poor prognosis in septic patients. Albumin is a molecule that is the most abundant protein in plasma. For a variety of physiological mechanisms, albumin has a variety of function, including serving as a major buffer, extracellular antioxidant, immune modulator, antidote and transporter in plasma. Increased capillary leakage of albumin is one of the features of SIRS. This means that lower albumin levels correlate with severe systemic inflammation and organ failure. Hypoxia and tissue hypo perfusion seen in sepsis play a key role on the development of multi-organ failure in septic patients. Lactic acidosis is one of the best indicators of the insufficient perfusion or development of anaerobic metabolism during septic shock. The inability of liver to metabolize lactate as a result of the deterioration of liver perfusion also increases lactate levels. The measurement of blood lactate levels used to determine tissue hypoxia is rapid, inexpensive and easy. Because lactate and albumin levels progress differently as the development of sepsis proceeds, a ratio between the two rather than analyzing lactate and albumin alone may be a new and perhaps better indicator for the patient's prognosis.

Official Title
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Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio as a Predictor of Morbidity and Mortality in Patients With Sepsis and Septic Shock

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age from 18 to 60 years old. Patients with suspected infection who fulfilled at least two of three quick sepsis - related organ failure assessment (QSOFA) criteria Patients with Organ dysfunction can be confirmed by acute change in SOFA score variables >2 points consequent to infection. Sepsis with persisting hypotension requiring vasopressors to maintain MAP > 65 mm Hg and having a serum lactate level > 2mmol/L despite adequate volume of resuscitation. Exclusion criteria No informed consent. Malignancy and chemotherapy during the previous 90 days. History of steroid therapy within 3 months before admission. Patients with either established hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burn.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.|Blood will be drawn from peripheral vein, arterial or a central catheter for evaluation of whole blood count, serum lactate and serum albumin.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of 28 day mortality. | Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of organ dysfunction in patients with sepsis and septic shock assessed by SOFA score | SOFA score for assessment of organ dysfunction in 0 hours, 6 hours, 24 hours of admission to icu. | 0 hours, 6 hours, 24 hours of admission to icu |