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临床试验/NCT03801044
NCT03801044已完成不适用

Comparison of Lung Ultrasound and Other Volumetric Methods in Peritoneal Dialysis Patients

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年5月1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
23
试验地点
1
主要终点
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay

研究概览

简要总结

Although many alternative methods are present, maintaining ideal volume status in peritoneal dialysis (PD) patients still rely on clinical evaluation due to lack of an evidence based method. Lung ultrasound (LUS) is a new method for evaluation of hidden congestion in this group. LUS findings and its relationship with other volumetric methods are investigated in this study. LUS was performed to all peritoneal dialysis patients and compared with symptoms of hypervolemia, physical examination, vascular endothelial growth factor-C (VEGF-C) and N-terminal pro-brain natriuretic peptide levels, chest radiography, echocardiography, bioelectrical impedance analysis.

详细描述

Maintaining volume control is crucial in all renal replacement therapy modalities. Fluid overload is associated with increased mortality both in hemodialysis patients and peritoneal dialysis (PD) patients although peritoneal dialysis has the advantage of better preservation of residual renal function compared to hemodialysis. Many methods have been used to fine tune the volume status of patients including physical examination, chest radiography, blood pressure, laboratory parameters, echocardiography, bioelectrical impedance analysis (BIA), ultrasound for lung.

Symptoms of hypervolemia are mainly paroxysmal nocturnal dyspnea, orthopnea, edema, dyspnea on exertion. On physical examination, hypertension or hypotension, third heart sound, jugular venous distension, rales, edema can be seen. Pulmonary venous congestion, cardiomegaly, interstitial edema, alveolar edema, pleural effusion can be seen on chest radiographies.

Level of N-terminal pro-brain natriuretic peptide (NT-proBNP) increases upon stretching of cardiac myocytes. This is accepted as a reflection of volume status. There are a few studies in which NT-proBNP was found as a useful marker for hypervolemia both in hemodialysis and peritoneal dialysis population.

Vascular endothelial growth factor-C (VEGF-C) is an osmosensitive gene product secreted by macrophages through activation of tonicity-responsive enhancer binding protein found in mononuclear phagocyte system cells infiltrating the interstitium. The result is hypertonic sodium accumulation in the skin which is accepted as a buffer mechanism maintaining blood pressure homeostasis. Serum VEGF-C levels had been found as a promising marker of hypervolemia in a hemodialysis patient cohort by a recent study.

Echocardiography has been used extensively in dialysis patients in which a number of parameters have been measured. Bioelectrical impedance analysis (BIA) is another non-invasive bedside method for the evaluation of volume status.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients older than 18 years old,
  • History of PD more than 3 months,
  • Providing written informed consent

排除标准

  • Patients younger than 18 years old,
  • Unwilling to participate to the study,
  • Immobile patients unable to perform test in the same day,
  • History of PD less than 3 months,
  • Presence of active infection,
  • History of lung cancer and/or operations.

结局指标

主要结局

Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay

时间窗: 4 months

Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay

次要结局

  • Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire(4 months)
  • Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography(4 months)
  • Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography(4 months)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuri Baris Hasbal

MD

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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