Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 7:38 AM
Study NCT ID:
NCT05706857
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2023-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the effect of Ultra Fast-track', 'timeFrame': '1 year', 'description': 'Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.'}], 'secondaryOutcomes': [{'measure': 'Procedural resources conpsumption', 'timeFrame': '1 year', 'description': 'Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).'}, {'measure': 'Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.', 'timeFrame': '1 year', 'description': 'Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for \\>24h after the procedure.'}, {'measure': 'Differences in major bleeding or life-threatening bleeding.', 'timeFrame': '1 year', 'description': 'Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).'}, {'measure': 'Differences in neurological complication', 'timeFrame': '1 year', 'description': 'Comparison of the incidence of neurological complication after the procedure.'}, {'measure': 'Differences in the incidence of acute myocardial infarction.', 'timeFrame': '1 year', 'description': 'Comparison of the incidence of acute myocardial infarction after the procedure.'}, {'measure': 'Differences in the incidence of heart reoperation', 'timeFrame': '1 year', 'description': 'Comparison of the reoperation rate after the procedure.'}, {'measure': 'Differences in the incidence of infections rate.', 'timeFrame': '1 year', 'description': "Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Disease', 'Surgery', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.', 'detailedDescription': 'The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 612 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.\n* The patient's desire to participate in the clinical trial verified by signing the informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Emergent surgery or cardiorespiratory arrest.\n3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.\n4. Aortic arch procedures.\n5. Procedures in which hypothermia \\< 28ºC of temperature is expected during the intervention.\n6. Minor cardiac surgery procedures.\n7. Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).\n8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).\n9. Active endocarditis."}, 'identificationModule': {'nctId': 'NCT05706857', 'acronym': 'CARDU-FAST', 'briefTitle': 'Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)', 'orgStudyIdInfo': {'id': '22/720-EC_X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultra fast-track', 'description': 'Patients are extubated in the operating room after the procedure', 'interventionNames': ['Behavioral: Ultra Fast-track']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional extubation', 'description': 'Patients are extubated in the intensive unit care', 'interventionNames': ['Behavioral: Ultra Fast-track']}], 'interventions': [{'name': 'Ultra Fast-track', 'type': 'BEHAVIORAL', 'description': 'Patients are extubated in the operating room', 'armGroupLabels': ['Conventional extubation', 'Ultra fast-track']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Lourdes Montero Cruces', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Carlos, Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiovascular Surgeon', 'investigatorFullName': 'Lourdes Montero Cruces', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}