Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT04176627
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of subclinical fluid overload in peritoneal dialysis patients', 'timeFrame': 'single monthly nurse visit', 'description': 'percentage of patients with moderate-severe lung congestion on ultrasound and nurse physical exam without fluid overload'}], 'secondaryOutcomes': [{'measure': 'Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients', 'timeFrame': 'single monthly nurse visit', 'description': 'percentage of patients with subclinical fluid overload who have a change in PD prescription or diuretics'}, {'measure': 'Association of patient characteristics with lung congestion', 'timeFrame': 'single monthly nurse visit', 'description': 'Odds ratios for lung congestion from subgroup analyses and logistic regression'}, {'measure': 'Agreement between nurse physical exam and lung ultrasound for fluid overload', 'timeFrame': 'single monthly nurse visit', 'description': 'kappa coefficient between lung ultrasound and nurse exam for fluid overload'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['fluid overload', 'peritoneal dialysis', 'lung ultrasound'], 'conditions': ['Fluid Overload Pulmonary Edema', 'Peritoneal Dialysis Complication']}, 'referencesModule': {'references': [{'pmid': '22573237', 'type': 'RESULT', '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. 2012 Sep;27(9):3601-5. doi: 10.1093/ndt/gfs116. Epub 2012 May 9.'}, {'pmid': '27660305', 'type': 'RESULT', '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, 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.'}, {'pmid': '23449536', 'type': 'RESULT', '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: 10.1681/ASN.2012100990. Epub 2013 Feb 28."}, {'pmid': '27672089', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '* 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.\n* 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.\n* Lung ultrasound is a relatively simple and cheap tool to assess for lung congestion, with little inter-operator variability and good reproducibility.\n* 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.\n\nAims of this study\n\n* This study aims to determine the prevalence of subclinical fluid overload in peritoneal dialysis patients.\n* The investigators aim to determine the added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients.\n* The investigators aim to assess the association of patient characteristics with lung congestion.\n* The investigators also aim to assess the agreement between nurse physical exam and lung ultrasound for fluid overload.', 'detailedDescription': 'Study Design:\n\n* 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.\n* Eligible patients approached for informed consent\n* 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\n* Training: lung ultrasound training modules accredited by American College of Emergency Physicians, in addition to dedicated rotation of ultrasound training during internal medicine residency.\n* Separate nurse clinical evaluation- yes or no, nurse blinded from ultrasound results\n* 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 (%)\n* 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.\n* 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\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Goal to enroll all potential peritoneal dialysis patients in clinic without symptomatic lung congestion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peritoneal dialysis patients seen at participating Wellbound clinics in Northern California, present for monthly visit on days in which lung ultrasound available\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT04176627', 'acronym': 'Fluid-PLUS', 'briefTitle': 'Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound', 'orgStudyIdInfo': {'id': 'SIH_122_Fluid-PLUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lung ultrasound', 'type': 'DEVICE', 'description': 'One-time lung ultrasound study completed on peritoneal dialysis patients at monthly clinic visit'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94014', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Daly City', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound Emeryville', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound Fremont', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '95035', 'city': 'Milpitas', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound Milpitas', 'geoPoint': {'lat': 37.42827, 'lon': -121.90662}}, {'zip': '95345', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'WellBound North Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound Mountain View', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'WellBound San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95125', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'WellBound San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Satellite WellBound San Mateo', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '95062', 'city': 'Santa Cruz', 'state': 'California', 'country': 'United States', 'facility': 'Wellbound Santa Cruz', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}, {'zip': '95407', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Santa Rosa', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '95219', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Stockton', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '94590', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Vallejo', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}], 'overallOfficials': [{'name': 'Wael Hussein, MBBS, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University, Satellite Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}