Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 5:26 PM
Study NCT ID:
NCT04264351
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty, Anesthesia and Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2020-02-08', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty as a risk factor of postoperative events.', 'timeFrame': '2017-2021', 'description': 'Assessment the prevalence of frailty in the surgical settings defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems. Frailty is defined as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss'}, {'measure': 'Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery', 'timeFrame': '2017-2021', 'description': 'Frailty is going to be evaluated in the anesthetic preoperative visit using the Short Physical Performance Battery (SPPB), Canadian Frailty Scale, Mini-Cog test (Memory an executive functions), Pfeiffer Test (Cognitive global screening), Involuntary loose of more than 4,5kg or 5% of weight in the previous year, physical activity using the Metabolic Equivalents of Task (MET).'}], 'secondaryOutcomes': [{'measure': 'Postoperative events and frailty', 'timeFrame': '2017-2021', 'description': 'Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.'}, {'measure': 'Mortality associated to frailty and its complications', 'timeFrame': '2017-2021', 'description': 'Assessment of the association between frailty and mortality at 30 days, 6 months and one year after the surgery.'}, {'measure': 'Preoperative visit as a chance to assess frailty', 'timeFrame': '2017-2021', 'description': 'Analyze which frailty evaluation tool works better in the preoperative visit setting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Anesthesia', 'complications'], 'conditions': ['Frail Elderly Syndrome', 'Anesthesia Complication', 'Complication of Surgical Procedure', 'Postoperative Delirium', 'Physical Disability']}, 'descriptionModule': {'briefSummary': 'Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.', 'detailedDescription': 'Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.\n\nMethods: prospective cohort study performed at Fundació Puigvert. Enrollment of 850 patients ≥70 y/o who undergo scheduled nephrourologic surgery. In the preoperative visit frailty is going to be evaluated using the Short Physical Performance Battery (SPPB), the Canadian Frailty Scale, the Mini-Cog test (Memory an executive functions), the Pfeiffer Test (Cognitive global screening), an involuntary loss of more than 4.5kg or 5% of weight in the previous year and physical activity using the Metabolic Equivalents of Task (MET). We will analyse the relation among frailty, medical, surgical postoperative complications and mortality at 30 days, 6 months and one year after the surgery.\n\nThe results will be adjusted by the possible confounding and interaction variables using a multivariate logistic regression model. The confounding /interaction variables will include demographic data, clinical and lab data and events arisen during the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing urological scheduled surgery in our centre, that fill in the inclusion criteria with no exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients who participate voluntarily\n* Signed Informed consent\n* 70+ years old\n* Scheduled urological surgery with general or regional anesthesia and length of stay in hospital over 24 hours.\n* Patients with preserved domiciliary deambulation without aid of another person. (walking sticks, or walkers are accepted)\n\nExclusion Criteria:\n\n* No signing of the informed consent\n* Surgery performed with local anesthetics\n* Day surgery, extracorporeal wave lithotripsy or endourological catheterism\n* Advanced diagnosed dementia\n* Patients with chronic advanced disease or terminal oncological disease'}, 'identificationModule': {'nctId': 'NCT04264351', 'acronym': 'FRAC', 'briefTitle': 'Frailty, Anesthesia and Complications.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacio Puigvert'}, 'officialTitle': 'Frailty, Anesthesia and Complications in an Urological Setting.', 'orgStudyIdInfo': {'id': 'FRAC1'}}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fundació Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Sergi Sabate, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chair Anesthesiologist at Fundació Puigvert'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacio Puigvert', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parc Sanitari Pere Virgili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Anesthesiology consultant', 'investigatorFullName': 'Merce Prieto Butillé', 'investigatorAffiliation': 'Fundacio Puigvert'}}}}