Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04466306
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Acute Kidney Injury in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury (AKI)', 'timeFrame': '14 days', 'description': 'Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '14 days', 'description': 'Survival to ICU discharge or Day 14'}, {'measure': 'Rate of Extracorporeal Therapy Requirement', 'timeFrame': '14 days', 'description': 'The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy'}, {'measure': 'Fluid overload', 'timeFrame': 'Day of Enrollment', 'description': '\\>20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight'}, {'measure': 'Rate of nephrotoxic medication exposure', 'timeFrame': 'Day of Enrollment', 'description': 'The exposure of enrolled patients to known nephrotoxic medications, including diuretics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'COVID']}, 'descriptionModule': {'briefSummary': 'This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.', 'detailedDescription': 'The primary purpose of the data collection will be to provide a descriptive analysis of the burden and characteristics of AKI in children with SARS-CoV2 proven or suspected infection across the world. This is a prospective, point prevalence study. Data collection will occur once a week during the months of April through June 2020.\n\nThe protocol for the point prevalence is for each individual participating site to conduct a surveillance study on predetermined dates of their intensive care units (pediatric medical, surgical, cardiac ICUs) for patients by the inclusion and exclusion criteria. The study is strictly observational. Data will only be captured on the predetermined dates listed. The dates have been chosen to reflect the estimated surge and peak of the virus spread in North America, Europe, Africa, Asia, and Australia. The rationale for performing an urgent point prevalence estimation study first, includes the following: a) there is almost no knowledge on AKI rate, severity of AKI or how current pandemic-setting AKI phenotype differs from what we know of AKI in children prior to the pandemic. A rapidly-performed, high feasibility-designed point prevalence estimation study, with minimal data collection will provide rapid, almost instantaneous dissemination of results to the international community. Based on the results of this study, a follow-up study is planned for a full retrospective data collection of all viral positive patients. Understanding the burden of pediatric AKI during this pandemic within the current context of acute health burden in the healthcare settings and enable planning and feasibility evaluation for quality of care measures and potentially for upcoming technology needs and/or sharing of RRT technology with adult care units; b) an urgent point-prevalence estimation study with minimal but key data collection will inform on any changes to design, sample size requirements or data points for the larger granular longitudinal retrospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '7 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the pediatric medical, surgical, or cardiac ICU for any condition - with a suspicion for or proven diagnosis of SARS-COV2 (COVID-19).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient less than or equal to 25 years of age\n* Receiving clinical care in the pediatric intensive care unit (PICU) on a study day in April - June 2020\n* Patient considered a "Person Under Investigation" and/or tested positive for SARS-CoV2 (COVID-19)\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT04466306', 'acronym': 'SPARC-1', 'briefTitle': 'Pediatric Acute Kidney Injury in COVID-19', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative', 'orgStudyIdInfo': {'id': 'ChildrensHA'}}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Cedars-Sinai Maxine Dunitz Children's Health Center", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "UCLA Mattel Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Standford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': "Yale New Haven Children's Hospital", 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': "UF Health Shands Children's Hospital", 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Comer Children's Hospital - UChicago Medicine", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': "University of Iowa Stead Family Children's Hospital", 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': "Children's Mercy", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "John Hopkins Children's Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Helen DeVos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': "Beaumont Children's Hospital", 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital of Washington University", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Oishei Children's Hospital of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': "Golisano Children's Hospital - University of Rochester Medicine", 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': "Stony Brook Children's Hospital", 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke Children's Hospital and Health Center", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn State Children's Hospital", 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "UPMC Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Lifespan Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Medical University of South Carolina Shawn Jenkins Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': "Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children (SickKids)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': "Dana-Dwek Children's Hospital", 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': "Shizuoka Children's Hospital", 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institute for Mother and Child Healthcare', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital NHS", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Alder Hey Children's Hospital NHS", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's University Hospital NHS", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital NHS', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Rajit K Basu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': "Children's of Alabama", 'class': 'OTHER'}, {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}