Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-31 @ 4:40 PM
Study NCT ID:
NCT07022951
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of fasting-related perioperative complications: pulmonary aspiration; patient well-being (anxiety, hunger, thirst); circulating blood volume-related complications (hypotension, myocardial and kidney injury); dysglycemia.', 'timeFrame': 'Perioperative period - while patient is located in the preoperative area, procedure area, or recovery area.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative fasting', 'perioperative pulmonary aspiration', 'perioperative complications', 'postoperative nausea and vomiting', 'perioperative hypoglycemia', 'perioperative hyperglycemia', 'perioperative hypotension', 'myocardial injury after noncardiac surgery', 'perioperative acute kidney injury', 'clear liquid fasting'], 'conditions': ['Anesthesia', 'Sedation', 'Monitored Anesthesia Care', 'Procedure', 'Surgery, Day', 'Surgery', 'Surgery Scheduled', 'Fasting Before Operation', 'Aspiration; Gastric Contents, Anesthesia']}, 'descriptionModule': {'briefSummary': "Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. We hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology.\n\nAdditional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include all anesthesia cases at participating institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)\n\nExclusion Criteria:\n\n* Not receiving anesthesia care\n* Lack of medical record data in Epic electronic medical record system'}, 'identificationModule': {'nctId': 'NCT07022951', 'acronym': 'MACS', 'briefTitle': 'The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Million Anesthesia Cases Study (MACS) - Retrospective and Prospective Characterization of Perioperative Fasting Practices and Their Effects on Clinical Outcomes', 'orgStudyIdInfo': {'id': '2023P001743'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who receive anesthesia care', 'interventionNames': ['Other: Preoperative fasting']}], 'interventions': [{'name': 'Preoperative fasting', 'type': 'OTHER', 'description': 'This cohort study assesses the duration of preoperative fasting and its clinical effects', 'armGroupLabels': ['Patients who receive anesthesia care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Nagrebetsky, MD, MSc', 'role': 'CONTACT', 'email': 'anagrebetsky@mgh.harvard.edu', 'phone': '617-724-3292'}], 'facility': 'Mass General Brigham', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Alexander Nagrebetsky, MD, MSc', 'role': 'CONTACT', 'email': 'anagrebetsky@mgh.harvard.edu', 'phone': '617-724-3292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-Investigator', 'investigatorFullName': 'Alexander Nagrebetsky, MD MSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}