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临床试验/NCT07089524
NCT07089524招募中不适用

A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis in Patients With Lower Respiratory Tract Infection in ICU

Ain Shams University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Detect the mortality due to sepsis with lower respiratory tract infection

研究概览

简要总结

Aim of this study is to predict the prognostic values of Neutrophil/ Lymphocyte ratio and Lactate/Albumin ratio in the outcome of patients with sepsis and septic shock with lower respiratory tract infection, also to compare between them regarding sensitivity and specificity.

详细描述

Lower respiratory tract infection (LRTI) is one of the most common infectious diseases that lead to admission of patients to ICU. It includes a wide range of respiratory infections; such as pneumonia, bronchitis, empyema and lung abscess. Furthermore, it is associated with considerable morbidity and mortality. Because delay in the ICU admission of patients with LRTI has been shown to be associated with increased mortality, it can be helpful to predict the mortality of LRTI patients in hospitals.

Sepsis is a life-threatening medical emergency induced by uncontrolled systemic inflammatory response of the host to infection. Without an early and aggressive management, sepsis can rapidly lead to organ failure, tissue hypoperfusion, and death. Bacterial infections cause most cases of sepsis, but it can also be a result of other infections; such as viral, fungal or parasitic infections. Sepsis-3 definitions for sepsis management were established in 2016 according to the Surviving Sepsis Campaign guidelines. They define sepsis as "a life-threatening organ dysfunction caused by a dysregulated host response to infection", and septic shock as "a subset of sepsis in which underling circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality".

According to Sepsis-3 criteria, sepsis and septic shock are currently diagnosed as follows: sepsis-suspected or documented infection plus SOFA (Sequential Organ Failure Assessment) score ≥2; septic shock-sepsis plus vasopressor therapy needed to maintain mean arterial pressure (MAP) ≥65 mmHg plus lactate ≥2 mmol/L (18 mg/L) despite adequate fluid resuscitation. However these diagnosis criteria, the early evaluation of sepsis severity and prognosis is still imprecise and significant research is being performed to address this issue.

The neutrophil/lymphocyte ratio (NLR) was studied in order to provide an easier way to diagnose sepsis. This ratio can be calculated both from the absolute number of neutrophils and lymphocytes, and from their relative number. The importance of this report derives from the fact that physiological stress causes an increase in the number of neutrophils and a decrease in the number of lymphocytes. Sepsis stimulates lymphocyte apoptosis, so this ratio is increased in these cases. Septic shock causes a dramatic decrease in lymphocyte count, so the NLR ratio increases significantly.

Increased lactate production is a prognostic marker of generalized hypoxia in distributive shock. Previous studies have reported that lactate levels are a dependable parameter in diagnosis, therapeutic evaluation, and prognosis in circulatory shock. Increased lactate levels are used worldwide for early diagnosis, management, and in risk stratification of patients with septic shock .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with lower respiratory tract infection
  • Confirmed septic patients (under the third international consensus definitions of sepsis and septic shock),
  • Admitted to intensive care unit.
  • Age (18-80) years.
  • Both genders.

排除标准

  • Age: < 18 years old, > 80 years old
  • Patient refusal.
  • Pregnancy.
  • Malignancy.
  • Pathology that could affect serum albumin concentrations prior to ICU admission as Malnutrition
  • Nephrotic syndrome
  • Liver Cirrhosis
  • Intestinal resection surgeries

结局指标

主要结局

Detect the mortality due to sepsis with lower respiratory tract infection

时间窗: From date of randomization until the date of death during the study period ( 12-18 months)

Detect the mortality due to sepsis and septic shock in patients with lower respiratory tract infection in ICU

The prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in Sepsis

时间窗: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )

predict the prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in the outcome of septic patients with lower respiratory tract infection in ICU

次要结局

  • The duration of intensive care unit stay(From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months ))
  • The requirement for vasoactive medications(From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months ))
  • Mechanical ventilatory support and renal replacement therapy(From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months ))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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