Trial Outcomes & Findings for Lung Ultrasound in PD Patients (NCT NCT03801044)

NCT ID: NCT03801044

Last Updated: 2020-04-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 23 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2020-04-08

Participant Flow

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.

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

Participant milestones

Measure	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
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PD Patients n=21 Participants 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
Age, Categorical <=18 years	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants
Sex: Female, Male Female	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=21 Participants
Region of Enrollment Turkey	21 participants n=21 Participants
Etiology of End-Stage Renal Disease Unknown	12 Participants n=21 Participants
Etiology of End-Stage Renal Disease Hypertension	2 Participants n=21 Participants
Etiology of End-Stage Renal Disease Diabetes Mellitus	2 Participants n=21 Participants
Etiology of End-Stage Renal Disease Familial Mediterrenean Fever	1 Participants n=21 Participants
Etiology of End-Stage Renal Disease Focal Segmental glomerulosclerosis	2 Participants n=21 Participants
Etiology of End-Stage Renal Disease Ig A Nephropathy	1 Participants n=21 Participants
Etiology of End-Stage Renal Disease Tuberous Sclerosis	1 Participants n=21 Participants
Duration of PD, months	22 Months n=21 Participants
PD modality, CAPD (%)	17 Participants n=21 Participants
Peritoneum Transport Type Low	1 Participants n=21 Participants
Peritoneum Transport Type Low-medium	10 Participants n=21 Participants
Peritoneum Transport Type High-medium	7 Participants n=21 Participants
Peritoneum Transport Type High	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 months

Population: All peritoneal dialysis patients in the clinic invited to the study. Two patients were excluded because of immobility

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

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay All patients	0.29 ng/ml Interval 0.23 to 0.34
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay B Line ≤ 1	0.25 ng/ml Interval 0.21 to 0.32
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay B Line > 1	0.33 ng/ml Interval 0.27 to 0.35

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire B Lines ≤ 1	25 percentage of participants
Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire B lines > 1	11.1 percentage of participants

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification B Lines ≤ 1	91.7 percentage of NYHA Class 1
Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification B lines > 1	100 percentage of NYHA Class 1

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination B Lines ≤ 1	0 Participants
Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination B lines > 1	0 Participants

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	4.75 cm Interval 4.12 to 5.25
Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography B lines > 1	4.3 cm Interval 4.1 to 4.75

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	1.0 cm Interval 0.9 to 1.1
Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography B lines > 1	1.0 cm Interval 0.85 to 1.1

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	1.0 cm Interval 0.9 to 1.1
Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography B lines > 1	0.9 cm Interval 0.85 to 1.05

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	61 percentage of ejection fraction Interval 49.7 to 65.0
Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography B lines > 1	60 percentage of ejection fraction Interval 60.0 to 62.5

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	100 ml Interval 76.7 to 128.7
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography B lines > 1	94 ml Interval 87.5 to 135.0

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	36 ml Interval 31.0 to 44.7
Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography B lines < 1	37 ml Interval 26.0 to 41.0

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	100.5 g/m2 Interval 70.2 to 129.5
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography B lines > 1	75 g/m2 Interval 69.5 to 92.0

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	78.5 cm/sec Interval 56.7 to 86.2
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography B lines > 1	74 cm/sec Interval 65.0 to 87.0

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

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

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
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 B Lines ≤ 1	11.6 rate Interval 9.8 to 12.6
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 B lines > 1	10.7 rate Interval 9.9 to 11.5

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography B Lines ≤ 1	24 mmHg Interval 20.0 to 33.2
Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography B lines > 1	24 mmHg Interval 19.0 to 29.0

SECONDARY outcome

Timeframe: 4 months

Population: PD patients (n=21)

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)

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
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) B Lines ≤ 1	0.8 liter Interval 0.007 to 2.05
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) B lines > 1	1.3 liter Interval 0.1 to 2.1

SECONDARY outcome

Timeframe: 4 months

Population: PD patients

Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay

Outcome measures

Measure	PD Patients n=21 Participants 21 PD patients treated in out unit were enrolled.
Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay B Lines ≤ 1	3024 pg/ml Interval 568.0 to 9397.0
Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay B lines > 1	2217 pg/ml Interval 885.0 to 3959.0

Adverse Events

PD Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mustafa Sevinc

Sisli Hamidiye Etfal Training and Research Hospital

Phone: 00905309291239

Email: musevinc@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place