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Идёт набор NCT07089524

A Comparative Study Between Neutrophil/Lymphocyte Ratio and Lactate/Albumin Ratio as Predictive Inflammatory Markers for Sepsis

Наблюдательное Sepsis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Sepsis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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 .

Albumin is a negative acute-phase protein, and its levels can reflect the magnitude of inflammation. In critically ill patients, the degree of hypoalbuminemia thus represents the severity of the inflammatory response. Consequently, it may be a prognostic biomarker in patients with sepsis .

Although lactate and albumin values independently predict mortality, the ratio of lactate to albumin (L/A ratio) is superior as a predictor to lactate or albumin alone. This result has been recorded in studies conducted in recent years .

Первичные конечные точки

  • Detect the mortality due to sepsis with lower respiratory tract infection [Срок оценки: From date of randomization until the date of death during the study period ( 12-18 months)]
  • The prognostic values of Neutrophil/Lymphocyte ratio and Lactate/Albumin ratio in Sepsis [Срок оценки: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )]
Вторичные конечные точки (3)
  • The duration of intensive care unit stay [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From date of randomization until the date of discharge from the ICU or death during the study period ( 12-18 months )]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Египет · 1 центр
  • Ain Shams university — Cairo

Идентификаторы

NCT: NCT07089524 · FMASU MD210/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗