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临床试验/NCT04434157
NCT04434157已完成不适用

Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte /Platelet Ratio With Clinical Complications and Mortality in COVID-19 Patients

Hospital Regional de Alta especialidad de Ixtapaluca1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2020年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
221
试验地点
1
主要终点
Clinical complications and Mortality

研究概览

简要总结

There is little information about the clinical characteristics and risk factors of Covid-19 in Latin American countries considering the ethnic differences and the high prevalence of obesity and cardiometabolic diseases. The aim of the study was to evaluate the association between laboratory tests and the risk of complications in SARS-CoV-2 infection and to determine their mortality risk factors in a sample of the Mexican population.

A retrospective cross-sectional study of the routinely collected data was performed in the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), State of Mexico. Adult patients (aged ≥18 years) with positive RT-PCR for SARS-CoV-2 and oxygen support that were admitted between March 28 and May 5, 2020, were included

详细描述

Data collection Data was collected deidentified admission from adult patients, with oxygen therapy. Data were extracted from clinical medical records and the electronic database of daily laboratory test results. Also, incomplete clinical records were included. The number of cases in the area during the study period determined the sample size, no formal hypotheses being implemented. All patients who met the inclusion criteria were included.

Study variables Demographic variables (sex and age), chronic medical histories (hypertension, diabetes and cancer), laboratory plasma, and serum-based biomarkers, as well as the mortality, mechanical ventilation, and length of stay, were considered. Leukocytosis was considered as a leucocyte count above 10 x 103/mcL, a cut point of INL> 10, d- dimer 500 U/L, DHL> 500U/L, low count of lymphocytes < 0·5103/mcL as risk factors exposure to death and mechanical ventilation.

A new variable was create combining the data of neutrophil count (ANC) and lymphocyte count (ALC) to obtain the neutrophil-to-lymphocyte ratio (NLR) (calculated dividing the ANC by the ALC).

Outcomes The hypothesis was formulated before the statistical analysis. Our primary outcomes were to 1) To describe the clinical characteristics of the Mexican population with SARS-CoV-2 infection, and 2) To determine the mortality risk factors in Covid-19.

Secondary outcomes included 1) To identify the chronic diseases related to Covid-19 in Mexican population and 2) To evaluate the differences in hematic and biochemical parameters between survivors and no survivors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients (aged ≥18 years)
  • Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary infection by COVID-19
  • Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
  • Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)

排除标准

  • Previous diagnosis of severe liver or kidney failure.
  • Patients with Human Immunodeficiency Virus (HIV) infection.
  • Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
  • Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
  • Patients with a diagnosis of active or non-active cancer.
  • Absence of a clinical record for monitoring the data.
  • Patients referred from other institutions for their medical care. Clinical records of patients who requested their voluntary discharge Clinical records that do not include information of the course of COVID-19 infection

结局指标

主要结局

Clinical complications and Mortality

时间窗: 10 days

To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients

Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio

时间窗: 10 days

To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets

次要结局

未报告次要终点

研究者

发起方
Hospital Regional de Alta especialidad de Ixtapaluca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Ramos-Peñafiel

Christian Ramos Peñafiel, MD, PhD

Hospital Regional de Alta especialidad de Ixtapaluca

研究点 (1)

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