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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patients | All PD patients treated in out unit were enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-BNP, VEGF | Diagnostic Test | VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics). |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay | Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire | Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire | 4 months |
| Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustafa Sevinc | Istanbul | Turkey (Türkiye) |
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Total 23 patients accepted to participate in the study, but two of them were excluded because of immobility and not being capable of proceeding with the diagnostic tests
All peritoneal dialysis patients in Sisli Hamidiye Etfal Training and Research Hospital, Nephrology Outpatient Clinic, Istanbul, Turkey have been invited to the study between May and September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | PD Patients | 21 PD patients treated in out unit were enrolled. NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics). Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PD Patients | 21 PD patients treated in out unit were enrolled. NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics). Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay | Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay | All peritoneal dialysis patients in the clinic invited to the study. Two patients were excluded because of immobility | Posted | Median | Inter-Quartile Range | ng/ml | 4 months |
|
|
4 months
Lung ultrasound is a non-invasive technique, we did not expect any side-effect. And we did not encounter.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PD Patients | 21 PD patients treated in out unit were enrolled. | 0 |
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The main limitation of this study is a limited number of patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Sevinc | Sisli Hamidiye Etfal Training and Research Hospital | 00905309291239 | musevinc@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2018 | Dec 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum samples for levels of vascular endothelial growth factor and N-terminal pro-brain natriuretic peptide
|
| Echocardiography | Diagnostic Test | Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography |
|
| Chest Radiography | Radiation | All radiographies were taken when the patient was standing erect position during deep inhalation. They were reported by an expert radiologist blinded to clinical data. Films taken at supine position or during exhalation were excluded. Chest radiographies were classified into 3 stages to reflect degree of hypervolemia. Stage 1 was redistribution defined as increased artery-to-bronchus ratio in the upper and middle lobes. Stage 2 was interstitial edema evident by Kerley B lines and peribronchial cuffing. Stage 3 was alveolar edema phase perihilar consolidation and air bronchograms, pleural fluid, increased width of the vascular pedicle, enlarged cardiac silhouette. |
|
| Lung Ultrasound | Diagnostic Test | It was performed by 28 area method which contains ultrasound examination from second to fifth intercostals spaces at parasternal region, midclavicular line, anterior and mid axillary lines. Lung ultrasound had been done by same radiologist who was an expertise in ultrasonography blinded to all other parameters. It was performed by 1,6 megaHertz convex probe when patient lying at the supine position. |
|
| Bioelectrical Impedence Analysis | Diagnostic Test | The Body Composition Monitor (BCM) (type 0BJA1394, Fresenius Medical Care AG & Co. KGaA, D-61343 Bad Homburg) was used for assessment of hydration status in patients. Peritoneal cavities were free of intraperitoneal fluid during measurement. Patients were accepted as normovolemic if their result were between -1.1lt and 1.1 lt. |
|
Assessing the relationship 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 | Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination | 4 months |
| Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) 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 | Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography | 4 months |
| Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 | Assessing the relationship 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 |
| Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography | Assessing the relationship 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 Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt) | Assessing the relationship 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)](streamdown:incomplete-link) | 4 months |
| Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay | Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay | 4 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etiology of End-Stage Renal Disease | Count of Participants | Participants |
|
| Duration of PD, months | Median | Inter-Quartile Range | Months |
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| PD modality, CAPD (%) | Count of Participants | Participants |
|
| Peritoneum Transport Type | Count of Participants | Participants |
|
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire | Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire | PD patients (n=21) | Posted | Number | percentage of participants | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification | Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification | PD patients (n=21) | Posted | Number | percentage of NYHA Class 1 | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination | Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination | PD patients (n=21) | Posted | Count of Participants | Participants | 4 months |
|
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | cm | 4 months |
|
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | cm | 4 months |
|
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| Secondary | Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | cm | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | percentage of ejection fraction | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | ml | 4 months |
|
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | ml | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | g/m2 | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | cm/sec | 4 months |
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| Secondary | 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 | Assessing the relationship 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 | PD patients (n=21) | Posted | Median | Inter-Quartile Range | rate | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography | Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography | PD patients (n=21) | Posted | Median | Inter-Quartile Range | mmHg | 4 months |
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| Secondary | 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) | Assessing the relationship 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)](streamdown:incomplete-link) | PD patients (n=21) | Posted | Median | Inter-Quartile Range | liter | 4 months |
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| Secondary | Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay | Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay | PD patients | Posted | Median | Inter-Quartile Range | pg/ml | 4 months |
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| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |