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

NCT04176627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2020-08-14

No results posted yet for this study

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

Interventions

DEVICE

Lung ultrasound

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

Sponsors & Collaborators

  • Satellite Healthcare

    lead OTHER

Principal Investigators

  • Wael Hussein, MBBS, MSc · Stanford University, Satellite Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-04-01
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176627 on ClinicalTrials.gov