Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound

NCT04176627 | Completed FDA Device

• 1 other identifier: SIH_122_Fluid-PLUS
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 16

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.

Conditions

Fluid Overload Pulmonary Edema; Peritoneal Dialysis Complication

Keywords

fluid overload; peritoneal dialysis; lung ultrasound

Outcome Measures

Primary Outcomes (1)

• Prevalence of subclinical fluid overload in peritoneal dialysis patients

  percentage of patients with moderate-severe lung congestion on ultrasound and nurse physical exam without fluid overload

  single monthly nurse visit

Secondary Outcomes (3)

• Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients

  single monthly nurse visit

• Association of patient characteristics with lung congestion

  single monthly nurse visit

• Agreement between nurse physical exam and lung ultrasound for fluid overload

  single monthly nurse visit

Interventions

Lung ultrasound DEVICE

One-time lung ultrasound study completed on peritoneal dialysis patients at monthly clinic visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Goal to enroll all potential peritoneal dialysis patients in clinic without symptomatic lung congestion

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Satellite Healthcare: lead

Study Sites (16)

WellBound Daly City

Daly City, California, 94014, United States

Location

Satellite WellBound Emeryville

Emeryville, California, 94608, United States

Location

Satellite WellBound Fremont

Fremont, California, 94538, United States

Location

Satellite WellBound Milpitas

Milpitas, California, 95035, United States

Location

WellBound Modesto

Modesto, California, 95345, United States

Location

WellBound North Modesto

Modesto, California, 95356, United States

Location

Satellite WellBound Mountain View

Mountain View, California, 94040, United States

Location

WellBound Sacramento

Sacramento, California, 95821, United States

Location

WellBound San Francisco

San Francisco, California, 94109, United States

Location

Satellite WellBound San Jose

San Jose, California, 95125, United States

Location

WellBound San Leandro

San Leandro, California, 94577, United States

Location

Satellite WellBound San Mateo

San Mateo, California, 94403, United States

Location

Wellbound Santa Cruz

Santa Cruz, California, 95062, United States

Location

WellBound Santa Rosa

Santa Rosa, California, 95407, United States

Location

WellBound Stockton

Stockton, California, 95219, United States

Location

WellBound Vallejo

Vallejo, California, 94590, United States

Location

Related Publications (4)

• 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.

  PMID: 22573237 RESULT

• 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.

  PMID: 27660305 RESULT

• 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.

  PMID: 23449536 RESULT

• 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.

  PMID: 27672089 RESULT

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wael Hussein, MBBS, MSc

  Stanford University, Satellite Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 25, 2019
• Study Start: December 2, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 30, 2020
• Last Updated: August 14, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)