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临床试验/NCT05472805
NCT05472805已完成不适用

The Relationship of Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Carotid Intima-Media Thickness in Chronic Kidney Disease Patients Undergoing Dialysis

Universitas Sebelas Maret1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Platelet-lymphocyte ratio (PLR)

研究概览

简要总结

This study aims to determine whether the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) can be used as predictors of coronary heart disease (CHD) in CKD patients undergoing dialysis at Moewardi General Hospital Surakarta. It was hypothesized that NLR and PLR, which have been identified as inflammatory biomarkers, would be significantly related to increased arotid intima-media thickness (CIMT) in CKD patients undergoing dialysis. This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022.

详细描述

This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022. All patients aged 18 years old or older, with a diagnosis of CKD stage V and on HD or CAPD based RRTs were included in the study. The presence of cardiovascular, neoplastic, chronic inflammatory, or infectious disease, and usage of immunosuppressants or antiplatelet drugs precludes the patient from participating in the study.

The main outcome in this study is the presence of a high risk of CHD characterized by CIMT ≥1 mm. The risk of CHD will be operated as categorical variable; CIMT <1 mm and CIMT ≥1 mm. The main predictors used in this study are NLR and PLR. The absolute values of neutrophils and platelets were divided by the absolute values of lymphocytes to get the NLR and PLR values, respectively. Several confounding variables were also considered, including age, gender, nutrition status, CKD duration, presence of diabetes mellitus, and other hematologic parameters. These hematologic parameters include hemoglobin, leukocyte count, platelet count, neutrophils, and lymphocytes. These predictors will be operated as numerical or categorical variables, accordingly.

Patients that met the inclusion and exclusion criteria will be asked to sign an informed consent followed by history-taking and blood sampling. The blood samples were then ordered for a routine hematology examination carried out using a hematology analyzer in the clinical pathology department. The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded.

The data were first exported to Microsoft Excel and then imported into Statistical Package for the Social Sciences (version 22) for quantitative statistical analysis software. All variables were subjected to descriptive statistics in order to describe the subject's frequency, percentage, means, and standard deviations prior to analysis. Homogeneity analysis was also performed in order to identify the factor of the confounding variable in the final analysis. Separate logistic regression models were performed to analyze the relationship between the main predictors and the main outcome. A separate analysis was conducted for each predictor. This study was approved by Health Research Ethics Committee in Moewardi General Hospital with the number: 1.320/XII/HREC/2020.

研究设计

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

入排标准

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

入选标准

  • diagnosis of CKD stage V
  • on HD or CAPD based RRTs

排除标准

  • cardiovascular, neoplastic, chronic inflammatory, or infectious disease
  • usage of immunosuppressants or antiplatelet drugs

结局指标

主要结局

Platelet-lymphocyte ratio (PLR)

时间窗: Only in admission

The absolute values of platelet that divided by the absolute values of lymphocytes

Neutrophil-lymphocyte ratio (NLR)

时间窗: Only in admission

The absolute values of neutrophils that divided by the absolute values of lymphocytes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurhasan Agung Prabowo

MD

Universitas Sebelas Maret

研究点 (1)

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