Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
NCT ID: NCT04176627
Last Updated: 2020-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2019-12-02
2020-06-30
Brief Summary
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* The clinical exam is the only tool used currently to monitor volume status of PD patients, and has been found to have poor sensitivity and specificity for lung congestion compared to lung ultrasound. In current practice, patients are seen and examined monthly at their home dialysis units by the nurses. The nephrologist separately examines the patient monthly, possibly days to weeks after the nurse visit, and potentially only quarterly with the use of telehealth visits.
* Lung ultrasound is a relatively simple and cheap tool to assess for lung congestion, with little inter-operator variability and good reproducibility.
* There are limited studies of lung ultrasound in peritoneal dialysis, and none in the United States. Lung ultrasound may be useful as an objective measure of lung congestion in patients without signs or symptoms of fluid overload.
Aims of this study
* This study aims to determine the prevalence of subclinical fluid overload in peritoneal dialysis patients.
* The investigators aim to determine the added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients.
* The investigators aim to assess the association of patient characteristics with lung congestion.
* The investigators also aim to assess the agreement between nurse physical exam and lung ultrasound for fluid overload.
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Detailed Description
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* Cross-sectional study, inviting PD patients at 10 Northern CA home dialysis units to participate. One-time ultrasound done during monthly nurse visit between December 2019 and March 2020. All patients present for their monthly visit at participating home dialysis units on days in which ultrasound available will be eligible, unless they had already completed an ultrasound for the study.
* Eligible patients approached for informed consent
* Ultrasound method: 28 areas of the anterior and lateral thorax examined for B lines, need at least 3 B lines in each field to be counted- recorded for future validation
* Training: lung ultrasound training modules accredited by American College of Emergency Physicians, in addition to dedicated rotation of ultrasound training during internal medicine residency.
* Separate nurse clinical evaluation- yes or no, nurse blinded from ultrasound results
* Patient characteristics obtained from dialysis EHR and form 2728: Age, gender (male sex %), race, ethnicity, case of ESRD, dialysis vintage (mo), PD modality, BMI, DM (%), SBP, DBP, albumin , # of antihypertensives, use of diuretic, use of icodextrin, PD Rx, 24 hour urine volume, lung disease (%), heart failure (%)
* Lung ultrasound info documented in EHR along with nurse evaluation. If moderate-severe lung congestion on ultrasound, nephrologist notified in person, by phone or fax.
* Prescription changes from nephrologist (diuretic adjustment, dextrose concentration change, addition of icodextrin, or none) within 2 weeks tracked in EHR and/or in person with dialysis nurse
* Sample size calculation- assuming 30% subclinical fluid overload prevalence, 95% confidence interval of prevalence of subclinical fluid overload with 10% margin of error-\> 81 patients
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Lung ultrasound
One-time lung ultrasound study completed on peritoneal dialysis patients at monthly clinic visit
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Satellite Healthcare
OTHER
Responsible Party
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Principal Investigators
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Wael Hussein, MBBS, MSc
Role: PRINCIPAL_INVESTIGATOR
Stanford University, Satellite Healthcare
Locations
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WellBound Daly City
Daly City, California, United States
Satellite WellBound Emeryville
Emeryville, California, United States
Satellite WellBound Fremont
Fremont, California, United States
Satellite WellBound Milpitas
Milpitas, California, United States
WellBound Modesto
Modesto, California, United States
WellBound North Modesto
Modesto, California, United States
Satellite WellBound Mountain View
Mountain View, California, United States
WellBound Sacramento
Sacramento, California, United States
WellBound San Francisco
San Francisco, California, United States
Satellite WellBound San Jose
San Jose, California, United States
WellBound San Leandro
San Leandro, California, United States
Satellite WellBound San Mateo
San Mateo, California, United States
Wellbound Santa Cruz
Santa Cruz, California, United States
WellBound Santa Rosa
Santa Rosa, California, United States
WellBound Stockton
Stockton, California, United States
WellBound Vallejo
Vallejo, California, United States
Countries
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References
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Panuccio V, Enia G, Tripepi R, Torino C, Garozzo M, Battaglia GG, Marcantoni C, Infantone L, Giordano G, De Giorgi ML, Lupia M, Bruzzese V, Zoccali C. Chest ultrasound and hidden lung congestion in peritoneal dialysis patients. Nephrol Dial Transplant. 2012 Sep;27(9):3601-5. doi: 10.1093/ndt/gfs116. Epub 2012 May 9.
Torino C, Gargani L, Sicari R, Letachowicz K, Ekart R, Fliser D, Covic A, Siamopoulos K, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Gueler F, Hannedouche T, Panichi V, Wiecek A, Pontoriero G, Sarafidis P, Klinger M, Hojs R, Seiler-Mussler S, Lizzi F, Siriopol D, Balafa O, Shavit L, Tripepi R, Mallamaci F, Tripepi G, Picano E, London GM, Zoccali C. The Agreement between Auscultation and Lung Ultrasound in Hemodialysis Patients: The LUST Study. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2005-2011. doi: 10.2215/CJN.03890416. Epub 2016 Sep 22.
Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
Gargani L, Sicari R, Raciti M, Serasini L, Passera M, Torino C, Letachowicz K, Ekart R, Fliser D, Covic A, Balafa O, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Shavit L, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Kraemer TD, Hannedouche T, Panichi V, Wiecek A, Pontoriero G, Sarafidis P, Klinger M, Hojs R, Seiler-Mussler S, Lizzi F, Onofriescu M, Zarzoulas F, Tripepi R, Mallamaci F, Tripepi G, Picano E, London GM, Zoccali C. Efficacy of a remote web-based lung ultrasound training for nephrologists and cardiologists: a LUST trial sub-project. Nephrol Dial Transplant. 2016 Dec;31(12):1982-1988. doi: 10.1093/ndt/gfw329. Epub 2016 Sep 26.
Other Identifiers
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SIH_122_Fluid-PLUS
Identifier Type: -
Identifier Source: org_study_id
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