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临床试验/NCT07019051
NCT07019051已完成不适用

Predictive Role of Echocardiographic Parameters for Hemodynamic Support Needs During Initiation of Continuous Venovenous Hemodiafiltration in ICU Patients

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月23日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI

研究概览

简要总结

This prospective observational study aims to evaluate whether transthoracic echocardiographic parameters-Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI), Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), S' wave velocity, and E/e' ratio-can predict hemodynamic instability at the initiation of sustained low-efficiency daily dialysis (SVVHDF) in intensive care unit (ICU) patients. The study will include adult patients requiring SVVHDF, and echocardiographic measurements will be performed prior to dialysis. The primary outcome is the need for hemodynamic support (vasopressors/inotropes or fluid resuscitation) or development of hypotension within the first 60 minutes of dialysis. The study aims to identify which of these parameters best predict the need for hemodynamic intervention, with the goal of supporting individualized dialysis planning and safer fluid management in critically ill patients.

详细描述

This prospective, single-center observational study is designed to investigate the predictive value of specific transthoracic echocardiographic (TTE) parameters in assessing the risk of hemodynamic instability during the initiation of sustained low-efficiency daily dialysis (SVVHDF) in critically ill patients. The primary focus is to determine whether measurements obtained immediately before dialysis-namely LVOT VTI, MAPSE, TAPSE, S', and E/e'-can identify patients at risk of hypotension or the need for hemodynamic support within the first hour of treatment.

All echocardiographic assessments will be performed by certified intensive care specialists or cardiologists using standard parasternal and apical windows. The parameters to be evaluated include:

LVOT VTI (Left Ventricular Outflow Tract Velocity-Time Integral):

Measured via pulsed wave Doppler from the apical 5-chamber view, this value reflects stroke volume and overall cardiac output. A low LVOT VTI may indicate hypovolemia or decreased systolic function.

MAPSE (Mitral Annular Plane Systolic Excursion):

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥18 years
  • Admission to the intensive care unit (ICU)
  • Clinical indication for initiation of continuous veno-venous hemodiafiltration (CVVHDF)
  • Ability to obtain adequate transthoracic echocardiographic (TTE) images prior to CVVHDF
  • Written informed consent obtained from the patient's legal representative

排除标准

  • Acute coronary syndrome, severe valvular disease, or pericardial effusion affecting cardiac function
  • Cardiac arrhythmias such as atrial fibrillation or ventricular tachycardia that interfere with accurate Doppler measurements
  • Presence of cardiac devices such as pacemakers, LVADs, or implantable cardioverter defibrillators (ICDs)
  • Poor echocardiographic window due to severe lung disease or chest wall abnormalities
  • Estimated life expectancy <24 hours or do-not-resuscitate (DNR) orders in place
  • Inability to obtain informed consent due to lack of legal representative
  • Transfer to another facility before CVVHDF initiation or change in renal replacement strategy (e.g., switch to peritoneal dialysis)
  • Incomplete echocardiographic measurement due to technical limitations

结局指标

主要结局

Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI

时间窗: Within the first 60 minutes of CVVHDF initiation

Hemodynamic instability will be recorded within the first 60 minutes after initiation of continuous veno-venous hemodiafiltration (CVVHDF). Instability is defined by the occurrence of any of the following: Mean arterial pressure (MAP) \< 65 mmHg, ≥30% decrease in MAP from pre-CVVHDF baseline, Initiation of vasopressors or inotropes, Administration of ≥500 mL of intravenous fluid bolus for resuscitation. Each patient's Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) will be measured by transthoracic echocardiography prior to CVVHDF initiation.

次要结局

  • Association Between Pre-Dialysis MAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF(Within the first 60 minutes of CVVHDF initiation)
  • Association Between Pre-Dialysis TAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF(Within the first 60 minutes of CVVHDF initiation)
  • Association Between Pre-Dialysis S' Wave Velocity (cm/s) Measured by Tissue Doppler Imaging and Hemodynamic Instability During the First 60 Minutes of CVVHDF(Within the first 60 minutes of CVVHDF initiation)
  • Association Between Pre-Dialysis E/e' Ratio and Hemodynamic Instability Within the First 60 Minutes of CVVHDF(Within the first 60 minutes of CVVHDF initiation)

研究者

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

Engin Ihsan Turan

principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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