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NCT04176627 · ClinicalTrials.gov registry record
Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
A clinical trial of Peritoneal Dialysis Complication and Fluid Overload Pulmonary Edema, sponsored by Satellite Healthcare.
- Completed
- Registry status
- 44
- Enrollment target
- 16
- Study locations
NCT04176627 is a study of Peritoneal Dialysis Complication and Fluid Overload Pulmonary Edema that has completed, run by Satellite Healthcare. The registered enrollment target is 44 participants. The trial reports 16 study locations across 1 state.
The verdict
NCT04176627, a study of Peritoneal Dialysis Complication and Fluid Overload Pulmonary Edema, has completed, sponsored by Satellite Healthcare.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
- 16
- Study locations
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 Studied
Interventions
- DEVICE Lung ultrasound
Study Locations (16)
California
- WellBound Daly City - Daly City
- Satellite WellBound Emeryville - Emeryville
- Satellite WellBound Fremont - Fremont
- Satellite WellBound Milpitas - Milpitas
- WellBound Modesto - Modesto
- WellBound North Modesto - Modesto
- Satellite WellBound Mountain View - Mountain View
- WellBound Sacramento - Sacramento
- WellBound San Francisco - San Francisco
- Satellite WellBound San Jose - San Jose
- WellBound San Leandro - San Leandro
- Satellite WellBound San Mateo - San Mateo
- Wellbound Santa Cruz - Santa Cruz
- WellBound Santa Rosa - Santa Rosa
- WellBound Stockton - Stockton
- WellBound Vallejo - Vallejo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-12-02 |
| Est. Completion | 2020-06-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04176627
The ClinicalTrials.gov registry entry for NCT04176627 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Satellite Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Peritoneal Dialysis Complication appearing as the primary indexed condition, and to 1 intervention - of which Lung ultrasound is the first listed.
NCT04176627 reports 16 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04176627 about?
NCT04176627 is a clinical study titled "Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound". * 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 o...
What is the current status of trial NCT04176627?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2019-12-02. Estimated completion is 2020-06-30.
What conditions does trial NCT04176627 study?
This clinical trial studies the following conditions: Peritoneal Dialysis Complication, Fluid Overload Pulmonary Edema.
What interventions are being tested in trial NCT04176627?
The interventions under investigation include: Lung ultrasound (DEVICE).
Who is sponsoring clinical trial NCT04176627?
This trial is sponsored by Satellite Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04176627 being conducted?
This trial has 16 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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