Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-07 @ 4:05 PM
Study NCT ID:
NCT02188602
Status:
WITHDRAWN
Last Update Posted:
2022-08-22
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Researcher left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury', 'timeFrame': '7 days', 'description': 'or sooner if death or discharged'}], 'secondaryOutcomes': [{'measure': 'PICU length of stay', 'timeFrame': '7 days'}, {'measure': 'Hospital length of stay', 'timeFrame': '7 days'}, {'measure': 'Number of ventilator days', 'timeFrame': '7 days'}, {'measure': 'Mortality', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The investigators would like to investigate the effect of chloride dosing on the development of acute kidney injury in critically ill patients. The investigators hypothesis is that administering intravenous fluids with higher chloride content are more likely to lead to acute kidney injury.', 'detailedDescription': 'Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride levels and their effects on acute kidney injury in the pediatric ICU. Patients will be included for the first seven days of their PICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children \\< 18 yo admitted to the Pediatric Intensive Care Unit at Lucile Packard Children's Hospital with admitting diagnosis of sepsis, respiratory failure, or liver failure", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age less than 18 years\n* PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.\n\nExclusion Criteria:\n\n* hyponatremia or hypernatremia at PICU admission\n* preexisting diagnosis of End-stage renal disease or renal transplant\n* presence of neurologic comorbidities.'}, 'identificationModule': {'nctId': 'NCT02188602', 'briefTitle': 'Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury', 'orgStudyIdInfo': {'id': '27752'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Chloride Dose', 'description': 'Patients receiving high dosing of chloride'}, {'label': 'Low Chloride Dose', 'description': 'Patients receiving low dosing of chloride'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Weiwen V Shih, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}