Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT04215692
Status:
SUSPENDED
Last Update Posted:
2025-05-02
First Post:
2019-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'whyStopped': 'Recruitment goal not met. Lack of personnel to complete the trial.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'through study completion, an average of 14 days', 'description': 'Number of days that the patient requires care in the ICU'}], 'secondaryOutcomes': [{'measure': 'Oxygenation Index', 'timeFrame': 'Daily through study completion, an average of 14 days', 'description': 'Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.'}, {'measure': 'PaO2/FIO2', 'timeFrame': 'Daily through study completion, an average of 14 days', 'description': 'Ratio of arterial oxygen partial pressure to fractional inspired oxygen'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'through study completion, an average of 14 days', 'description': 'Days that a patient remains under mechanical ventilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric intensive care', 'lenght of stay'], 'conditions': ['Fluid Overload Pulmonary Edema', 'Fluid Overload', 'Pneumonia, Ventilator-Associated', 'Fluid Overload Without Edema']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.', 'detailedDescription': 'In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:\n\nLength of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pediatric inpatient intensive care unit admissions\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Cyanotic congenital heart disease\n* Not requiring mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT04215692', 'briefTitle': 'Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': '2019-R-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Guided Fluid Therapy', 'interventionNames': ['Diagnostic Test: Pulmonary ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Fluid Therapy'}], 'interventions': [{'name': 'Pulmonary ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.', 'armGroupLabels': ['Ultrasound Guided Fluid Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20259', 'city': 'Aguascalientes', 'state': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Centenario Hospital Miguel Hidalgo', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are not planning to share the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centenario Hospital Miguel Hidalgo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juan Manuel Marquez Romero', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}