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

Peritoneal Dialysis Complication Clinical Trial

— Fluid-PLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176627
• Other study ID #: SIH_122_Fluid-PLUS
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2019
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload Pulmonary Edema
• Peritoneal Dialysis Complication
• Pulmonary Edema

Intervention

Device:
• Lung ultrasound
One-time lung ultrasound study completed on peritoneal dialysis patients at monthly clinic visit

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (4)

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, — View 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. 20 — View 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, Wi — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients	percentage of patients with subclinical fluid overload who have a change in PD prescription or diuretics	single monthly nurse visit
Secondary	Association of patient characteristics with lung congestion	Odds ratios for lung congestion from subgroup analyses and logistic regression	single monthly nurse visit
Secondary	Agreement between nurse physical exam and lung ultrasound for fluid overload	kappa coefficient between lung ultrasound and nurse exam for fluid overload	single monthly nurse visit