Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04675918
Status:
RECRUITING
Last Update Posted:
2021-01-19
First Post:
2020-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006324', 'term': 'Heart Arrest, Induced'}], 'ancestors': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Through study completition an average of 3 years', 'description': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Neurological outcome', 'timeFrame': '5 years', 'description': 'Neurological outcome (Scales: Pediatric Cerecral Performance Category Scale and Pediatric Overall Performance Category Scale. Assesment of neurological outcome with both scales which attempt to measure the same items in neurological development in pediatric patients. Values of 1 or 2 describe normal recovery whilst values of 5-6 define brain death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric cardiac arrest', 'outcomes', 'survival', 'cardiopulmonary resuscitation'], 'conditions': ['Cardiac Arrest', 'Pediatric ALL', 'In-hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '34332522', 'type': 'DERIVED', 'citation': 'Del Castillo J, Sanz D, Herrera L, Lopez-Herce J; Grupo de Estudio de Parada Cardiaca Intrahospitalaria en la Infancia. Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): protocol for a prospective international multicenter register of cardiac arrest in children. BMC Cardiovasc Disord. 2021 Jul 31;21(1):365. doi: 10.1186/s12872-021-02173-5.'}]}, 'descriptionModule': {'briefSummary': ": An intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them", 'detailedDescription': "Study design: this study is a multicenter, international, prospective observational registry.\n\nSetting: patients will be enrolled by participating investigators from European and Latinamerican countries. All sites are susceptible of treating pediatric cardiac arrest patients. Participating hospitals differ in levels of care but are all able to submit their data to the study's database.\n\nPatient elegibility: Inclusion criteria: all children aged 1 month to 18 years who suffer a CA in hospital. For the study, CA is defined as the absence of vital signs requiring at least one minute of chest compressions. Subsequent episodes of CA may be included for the same individual.\n\nExclusion criteria: Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA. Patients who suffer a cardiac arrest and require ECMO for ROSC, after performing conventional CPR, will not be excluded. Duration of the data collection period 24 months.\n\nRecruitment: Study candidates will be identified by a study physician, who will explain the study to parents or guardians. Written informed consent will be obtained from parents or guardians prior to inclusion in the study. A CONSORT (Consolidated Standard of Reporting Trials) flow diagram is shown in Figure 1.\n\nData collection: data will be collected, verified, and uploaded to a protected electronic web-based database (Xolomon) by their designated site coordinators/investigators under the oversight of their IRB. Database has been designed following the Utstein model (19). Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who suffer a cardiac arrest in hospital premises and are resuscitated with at least 1 minute of cardiopulmonary resuscitation measures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all children aged 1 month to 18 years who suffer a CA in hospital\n\nExclusion Criteria:\n\n* Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.\n* Duration of resuscitation \\< 1minute'}, 'identificationModule': {'nctId': 'NCT04675918', 'acronym': 'PACHIN', 'briefTitle': 'Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.', 'orgStudyIdInfo': {'id': 'ESCE-RCP 2.0'}, 'secondaryIdInfos': [{'id': 'PI18/01632', 'type': 'OTHER_GRANT', 'domain': 'ISCIII'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac arrest', 'type': 'PROCEDURE', 'description': 'Definition of characteristics of cardiac arrest and resuscitation as well as post-resuscitational care and follow up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28009', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jimena del Castillo, MD PhD', 'role': 'CONTACT', 'email': 'jimenadelcastillo@yahoo.es', 'phone': '+34 630445620'}, {'name': 'Jesús López-Herce, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gregorio Marañon Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jimena del Castillo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jimena del Castillo', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}