Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT04374058
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2020-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Less Frequency Hemodialysis and COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-02', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-02', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From date of beginning of the study until the date of death assessed up to 52 weeks', 'description': 'Time to all-cause and cardiovascular death'}], 'secondaryOutcomes': [{'measure': 'Anemia, Nutrition, Adequation of dialysis, total ultrafiltration, ultrafiltration rate,', 'timeFrame': 'From date of beginning of the study assessed up to 52 weeks', 'description': 'Time variation of the biological parameters mentioned in the title. Repeated measurements of laboratory variables will be averaged into patient quarterly means to minimize measurement variability.'}, {'measure': 'Hospitalization', 'timeFrame': 'From date of beginning of the study until the date of first hospitalization assessed up to 52 weeks', 'description': 'Time to first hospitalization of any cause'}, {'measure': 'Vascular Access', 'timeFrame': 'From date of beginning of the study until the date of first intervention assessed up to 52 weeks', 'description': 'Time to first endovascular or quirurgical intervention of the vascular access utilized at the start of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Dialysis', 'less frequency hemodialysis', 'Ultrafiltration rate', 'Anemia', 'Nutrition'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Facing the unusual situation imposed by the coronavirus disease, the aim of this study is to evaluate the risk and effects of less frequent hemodialysis on prevalent patients', 'detailedDescription': 'The novel coronavirus disease (COVID-19), also known as COVID-19 (and SARS-Cov2) by the World Health Organization, is a rapidly evolving pandemic. The outbreak is expected to infect a large portion of the world population, and a case fatality rate of 1-3% represents a significant mortality and healthcare burden. In common with other viral diseases, mortality is higher in elderly patients with high comorbidity.\n\nThe impressive figures of transmission in different communities underline the need for reorganization of efforts to limit contagion, particularly in crowded settings. Hemodialysis centres represents a specific setting in which many patients are repeatedly treated in the same area at the same time.\n\nDialysis patients constitute a susceptible population because of their older age, high comorbidity burden and their less efficient immune system. Therefore, they are more prone to develop severe infectious diseases than the general population.. Moreover, if infected, the requirements of specialized resources and staff is further complicated by requirements for isolation, control and prevention, putting healthcare systems under additional strain. Therefore, all measures to slow and to control unmanageably high incidence rates must be taken very seriously.\n\nThe routine treatment usually requires three dialysis sessions per week Further, some patients must travel long distances to the dialysis centre. One option to reduce the higher risk of these patients is to reduce the frequency of dialysis sessions.However, the potential benefits of reduced risk may be associated with higher interdialytic weight gain and inadequate dialysis, Two factors that increase the risk of mortality. Furthermore, the impact of reduced frequency on Anemia and Nutrition have not been extensively studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The entire population of our satellite hemodialysis center, except those that meet the exclusion criteria, would be followed by one year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 30 days of Chronic ambulatory in-center hemodialysis\n\nExclusion Criteria:\n\n* More than three sessions a week\n* amputated lower limbs'}, 'identificationModule': {'nctId': 'NCT04374058', 'briefTitle': 'Less Frequency Hemodialysis and COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Dialisis Madariaga'}, 'officialTitle': 'Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease', 'orgStudyIdInfo': {'id': 'coronavirus'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Two Times', 'description': 'The treatment group consists of selected patients that, based on their mean ultrafiltration rate, are switched from thrice-weekly to twice-weekly hemodialysis sessions', 'interventionNames': ['Other: less-frequency hemodialysis']}, {'label': 'Three times', 'description': 'Usual thrice-weekly hemodialysis schedule', 'interventionNames': ['Other: less-frequency hemodialysis']}], 'interventions': [{'name': 'less-frequency hemodialysis', 'type': 'OTHER', 'description': 'Patients of treatment group would be evaluated quarterly', 'armGroupLabels': ['Three times', 'Two Times']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7167', 'city': 'General Juan Madariaga', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Dialisis Madariaga', 'geoPoint': {'lat': -37.00196, 'lon': -57.13584}}], 'overallOfficials': [{'name': 'Esteban L Siga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dialisis Madariaga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dialisis Madariaga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}