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临床试验/NCT06476171
NCT06476171招募中不适用

Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients.

Petrovsky National Research Centre of Surgery2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Number of patients with onset of complications of any type in the postoperative period

研究概览

简要总结

The hypothesis of the study is that hematological indices (neutrophil to lymphocyte ratio, platelet to lymphocyte ratio and systemic index of inflammation) may be predictors of infectious complications and multiple organ dysfunction in patients after cardiac surgery.

详细描述

The hematological index validation study is a single-center interventional prospective study. The aim of the study: to determine the average and threshold values of hematological indices in patients with cardiac surgery before surgery and in the early postoperative period; to determine the levels of hematological indices that indicate an unfavorable course of the postoperative period and may be predictors of infection or multiple organ dysfunction. The study will include 200 patients who are shown cardiac surgery. Blood samples will be collected before the study at three stages: before the operation, on the first day after the operation and on the third day after the operation. Based on the hematological indices studied (NLR, PLR, SII), other biomarkers often used in clinical practice (presepsin, procalcitonin, interleukins, etc.) will also be determined. Each patient will be monitored throughout the perioperative period until the patient is discharged from the hospital by the study participants, in the future all records from the medical history will also be analyzed., including data from instrumental and laboratory studies, consultations of specialists. Based on these data, patients will be divided into groups depending on the presence of complications and their nature. Data concerning demographic indicators, the levels of biomarkers studied and the course of postoperative will be stored in the Exel program. Statistical analysis is planned to be carried out in the IBM SPSS Statistics program. For each quantitative indicator, the nature of the distribution will be determined using the Kolmogorov-Smirnov criterion. All quantitative data with a normal distribution will be presented in the form of mean and standard deviation; with a distribution other than normal - in the form of a median (Q2) and an interquartile span (Q1; Q3). Parametric and nonparametric criteria will be used to assess the differences between the samples, depending on the nature of the distribution. It is planned to complete the correlation analysis performed; assessment of the influence of independent variables on dependent, encoded binary, using logistic regression; construction of ROC curves. It is planned to calculate the odds ratio (OR), 95% confidence interval (CI) and the significance of the influence of p. In all cases, the results of statistical analysis are considered significant at p < 0.05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • age from 18 to 80 years
  • cardiac surgery
  • operation in the conditions of cardiopulmonary bypass
  • availability of voluntary informed consent of the patient to participate in the study

排除标准

  • refusal of the patient from the study
  • transfer of the patient to another medical institution

结局指标

主要结局

Number of patients with onset of complications of any type in the postoperative period

时间窗: Up to 12 weeks

Recording by the attending physician of the occurrence of a complication

次要结局

  • Changes in the levels of other biomarkers often used in clinical practice(Up to 1 week)
  • Number of patients with sepsis(Up to 12 weeks)
  • Number of patients with wound infection(Up to 12 weeks)
  • Number of patients with multiple organ dysfunction(Up to 12 weeks)
  • Number of patients with nosocomial pneumonia(Up to 12 weeks)

研究者

发起方
Petrovsky National Research Centre of Surgery
申办方类型
Other
责任方
Sponsor

研究点 (2)

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