Clinical trial NCT04176627: Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
Official title: Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Overload Pulmonary Edema
Peritoneal Dialysis Complication
Keywords: fluid overload
peritoneal dialysis
lung ultrasound
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Goal to enroll all potential peritoneal dialysis patients in clinic without symptomatic lung congestion

Brief summary: * As studied previously, lung congestion is very prevalent however usually asymptomatic in dialysis patients. Fluid overload is associated with hospitalizations, worse cardiovascular outcomes and mortality in PD patients.
* 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.

Detailed description: Study Design:

* 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

Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis patients seen at participating Wellbound clinics in Northern California, present for monthly visit on days in which lung ultrasound available

Exclusion Criteria:

* Age \<18, on peritoneal dialysis \<3 mo, symptomatic lung congestion (reporting new or worsening shortness of breath over the past 4 weeks on enrollment), patient or nephrologist unwilling to participate in study

Primary outcomes:
measure: Prevalence of subclinical fluid overload in peritoneal dialysis patients
timeFrame: single monthly nurse visit
Secondary outcomes:
measure: Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients
timeFrame: single monthly nurse visit
measure: Association of patient characteristics with lung congestion
timeFrame: single monthly nurse visit
measure: Agreement between nurse physical exam and lung ultrasound for fluid overload
timeFrame: single monthly nurse visit
Other outcomes:
Locations:
city: Daly City
country: United States
facility: WellBound Daly City
state: California
city: Emeryville
country: United States
facility: Satellite WellBound Emeryville
state: California
city: Fremont
country: United States
facility: Satellite WellBound Fremont
state: California
city: Milpitas
country: United States
facility: Satellite WellBound Milpitas
state: California
city: Modesto
country: United States
facility: WellBound Modesto
state: California
city: Modesto
country: United States
facility: WellBound North Modesto
state: California
city: Mountain View
country: United States
facility: Satellite WellBound Mountain View
state: California
city: Sacramento
country: United States
facility: WellBound Sacramento
state: California
city: San Francisco
country: United States
facility: WellBound San Francisco
state: California
city: San Jose
country: United States
facility: Satellite WellBound San Jose
state: California
city: San Leandro
country: United States
facility: WellBound San Leandro
state: California
city: San Mateo
country: United States
facility: Satellite WellBound San Mateo
state: California
city: Santa Cruz
country: United States
facility: Wellbound Santa Cruz
state: California
city: Santa Rosa
country: United States
facility: WellBound Santa Rosa
state: California
city: Stockton
country: United States
facility: WellBound Stockton
state: California
city: Vallejo
country: United States
facility: WellBound Vallejo
state: California
Study officials:
affiliation: Stanford University, Satellite Healthcare
name: Wael Hussein, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.