Peritoneal DialysisLUSiPDNCT03801044
Lung Ultrasound in PD Patients
An observational study of Peritoneal Dialysis and Hypervolemia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Hypervolemia, VEGF Overexpression
- What is being tested?
- NT-BNP, VEGF, Echocardiography and Chest Radiography
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients older than 18 years old,
- History of PD more than 3 months,
- Providing written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Lung Ultrasound and Other Volumetric Methods in Peritoneal Dialysis Patients
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.
Read the 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.
- Conditions
- Peritoneal Dialysis, Hypervolemia, VEGF Overexpression
- Being tested
- NT-BNP, VEGF, Echocardiography, Chest Radiography, Lung Ultrasound, Bioelectrical Impedence Analysis
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-BNP, VEGFDiagnostic 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).
EchocardiographyDiagnostic 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 RadiographyRadiation
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 UltrasoundDiagnostic 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 AnalysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | All PD patients treated in out unit were enrolled. Receives: Diagnostic Test: NT-BNP, VEGF; Diagnostic Test: Echocardiography; Radiation: Chest Radiography; Diagnostic Test: Lung Ultrasound; Diagnostic Test: Bioelectrical Impedence Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (15)
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
Measured: 4 months
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 May 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuri Baris Hasbal, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801044
- Sponsor's protocol ID
- 1908
- Acronym
- LUSiPD
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2018
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Ultrasound and Other Volumetric Methods in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03801044
- Acronym / sponsor ID
- LUSiPD / 1908
- Conditions
- Peritoneal Dialysis, Hypervolemia, VEGF Overexpression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Diagnostic Test: NT-BNP, VEGF, Diagnostic Test: Echocardiography, Radiation: Chest Radiography, Diagnostic Test: Lung Ultrasound, Diagnostic Test: Bioelectrical Impedence AnalysisAll PD patients treated in out unit were enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients older than 18 years old,
- History of PD more than 3 months,
- Providing written informed consent
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-BNP, VEGFVEGF-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). | Diagnostic test | PD patients |
| EchocardiographyTransthoracic 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 | Diagnostic test | PD patients |
| Chest RadiographyAll 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. | Radiation | PD patients |
| Lung UltrasoundIt 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. | Diagnostic test | PD patients |
| Bioelectrical Impedence AnalysisThe 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. | Diagnostic test | PD patients |
Primary outcome
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay
Time frame: 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
15 secondary outcomes
Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography
Time frame: 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
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography
Time frame: 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)
Time frame: 4 months
Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis and Hypervolemia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.