- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04176627
Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound (Fluid-PLUS)
August 12, 2020 updated by: Satellite Healthcare
- 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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Daly City, California, United States, 94014
- WellBound Daly City
-
Emeryville, California, United States, 94608
- Satellite WellBound Emeryville
-
Fremont, California, United States, 94538
- Satellite WellBound Fremont
-
Milpitas, California, United States, 95035
- Satellite WellBound Milpitas
-
Modesto, California, United States, 95345
- WellBound Modesto
-
Modesto, California, United States, 95356
- WellBound North Modesto
-
Mountain View, California, United States, 94040
- Satellite WellBound Mountain View
-
Sacramento, California, United States, 95821
- WellBound Sacramento
-
San Francisco, California, United States, 94109
- WellBound San Francisco
-
San Jose, California, United States, 95125
- Satellite WellBound San Jose
-
San Leandro, California, United States, 94577
- WellBound San Leandro
-
San Mateo, California, United States, 94403
- Satellite WellBound San Mateo
-
Santa Cruz, California, United States, 95062
- Wellbound Santa Cruz
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Santa Rosa, California, United States, 95407
- WellBound Santa Rosa
-
Stockton, California, United States, 95219
- WellBound Stockton
-
Vallejo, California, United States, 94590
- WellBound Vallejo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Goal to enroll all potential peritoneal dialysis patients in clinic without symptomatic lung congestion
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of subclinical fluid overload in peritoneal dialysis patients
Time Frame: single monthly nurse visit
|
percentage of patients with moderate-severe lung congestion on ultrasound and nurse physical exam without fluid overload
|
single monthly nurse visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients
Time Frame: single monthly nurse visit
|
percentage of patients with subclinical fluid overload who have a change in PD prescription or diuretics
|
single monthly nurse visit
|
Association of patient characteristics with lung congestion
Time Frame: single monthly nurse visit
|
Odds ratios for lung congestion from subgroup analyses and logistic regression
|
single monthly nurse visit
|
Agreement between nurse physical exam and lung ultrasound for fluid overload
Time Frame: single monthly nurse visit
|
kappa coefficient between lung ultrasound and nurse exam for fluid overload
|
single monthly nurse visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wael Hussein, MBBS, MSc, Stanford University, Satellite Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 21, 2019
First Posted (Actual)
November 25, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIH_122_Fluid-PLUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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