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Fluid Overload Pulmonary EdemaFluid-PLUSNCT04176627

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

An observational study of Fluid Overload Pulmonary Edema and Peritoneal Dialysis Complication, run by Satellite Healthcare at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lung ultrasound
Type of treatment
Medical device
How many people
44 participants
Where
16 sitesUnited States
Study dates
2 Dec 2019to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • WellBound Daly City

    Daly City, California, 94014

  • Satellite WellBound Emeryville

    Emeryville, California, 94608

  • Satellite WellBound Fremont

    Fremont, California, 94538

  • Satellite WellBound Milpitas

    Milpitas, California, 95035

  • WellBound Modesto

    Modesto, California, 95345

  • WellBound North Modesto

    Modesto, California, 95356

  • Satellite WellBound Mountain View

    Mountain View, California, 94040

  • WellBound Sacramento

    Sacramento, California, 95821

  • WellBound San Francisco

    San Francisco, California, 94109

  • Satellite WellBound San Jose

    San Jose, California, 95125

  • WellBound San Leandro

    San Leandro, California, 94577

  • Satellite WellBound San Mateo

    San Mateo, California, 94403

  • Wellbound Santa Cruz

    Santa Cruz, California, 95062

  • WellBound Santa Rosa

    Santa Rosa, California, 95407

  • WellBound Stockton

    Stockton, California, 95219

  • WellBound Vallejo

    Vallejo, California, 94590

Other trials in United States

About this study

  • 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.
Read the 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
Being tested
Lung ultrasound
Keywords
fluid overload, peritoneal dialysis, lung ultrasound
Medical subject headings
Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: single monthly nurse visit

Secondary outcomes (3)

  1. 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

    Measured: single monthly nurse visit

  2. Association of patient characteristics with lung congestion

    Odds ratios for lung congestion from subgroup analyses and logistic regression

    Measured: single monthly nurse visit

  3. Agreement between nurse physical exam and lung ultrasound for fluid overload

    kappa coefficient between lung ultrasound and nurse exam for fluid overload

    Measured: single monthly nurse visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start2 Dec 2019
  3. Primary completion1 Apr 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176627
Sponsor's protocol ID
SIH_122_Fluid-PLUS
Acronym
Fluid-PLUS
Status last verified
Nov 2019
First submitted
19 Nov 2019
Last updated
14 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 22573237

  • 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.

    PubMed 27660305

  • 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.

    PubMed 23449536

  • 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.

    PubMed 27672089

Questions about this trial

What is this clinical trial studying?

An observational study of Fluid Overload Pulmonary Edema and Peritoneal Dialysis Complication, run by Satellite Healthcare at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of subclinical fluid overload in peritoneal dialysis patients (time frame: single monthly nurse visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04176627, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

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