Clinical trial NCT03801044: Lung Ultrasound in PD Patients
Official title: Comparison of Lung Ultrasound and Other Volumetric Methods in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Hypervolemia
VEGF Overexpression
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All peritoneal dialysis patients in the clinic have been invited to the study. Twenty three patients were enrolled to the study. Two patients excluded from study because of immobility.

Brief summary: 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.

Detailed description: 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.

Lung ultrasound (LUS) is a technique that has become popular in nephrology recently. "B lines" or "lung comets" are the reverberation artifacts arising from the pleural line. They are produced due to thickened subpleural interlobular septa by edema.

The gold standard for volume assessment is isotope dilution and neutron activation analysis methods which are only limited to research activities. The best widely accepted, non-invasive, practical, easy to access method has not been decided yet. Moreover evidence is quite scarce for the peritoneal dialysis than hemodialysis or normal renal functioning group. Lung ultrasound is the most recent promising method for volume control.

The investigators aimed to define lung ultrasound findings in our peritoneal dialysis cohort and its relation with other volumetric parameters.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay
timeFrame: 4 months
Secondary outcomes:
measure: Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: 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
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography
timeFrame: 4 months
measure: 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)
timeFrame: 4 months
measure: Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay
timeFrame: 4 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Mustafa Sevinc
Study officials:
References: