Lung Ultrasound in PD Patients

NCT03801044 | Completed Results

• 1 other identifier: 1908
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis; Hypervolemia; VEGF Overexpression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Association 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

  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 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

  4 months

Study Arms (1)

PD patients

All PD patients treated in out unit were enrolled.

Diagnostic Test: NT-BNP, VEGF; Diagnostic Test: Echocardiography; Radiation: Chest Radiography; Diagnostic Test: Lung Ultrasound; Diagnostic Test: Bioelectrical Impedence Analysis

Interventions

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).

PD patients

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

PD patients

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.

PD patients

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.

PD patients

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.

PD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Mustafa Sevinc

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for levels of vascular endothelial growth factor and N-terminal pro-brain natriuretic peptide

MeSH Terms

Conditions

Edema

Interventions

Echocardiography; X-Rays

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

The main limitation of this study is a limited number of patients.

Results Point of Contact

• Title: Mustafa Sevinc
• Organization: Sisli Hamidiye Etfal Training and Research Hospital

musevinc@hotmail.com

00905309291239

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 11, 2019
• Study Start: May 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 8, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)