Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-02 @ 3:55 AM
Study NCT ID:
NCT05362266
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of major adverse cardiac events', 'timeFrame': 'during hospital stay, up to 4 weeks', 'description': 'Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke'}], 'secondaryOutcomes': [{'measure': 'Incidence of the perioperative complication', 'timeFrame': 'during hospital stay, up to 4 weeks', 'description': 'Incidence of the perioperative other complication, which are major bleeding, repercussion syndrome, compartment syndrome, rhabdomyolysis and unplanned ICU admission from any causes.'}, {'measure': 'Factors contribute to the adverse outcome', 'timeFrame': 'during hospital stay, up to 4 weeks', 'description': "Factors contribute to the adverse outcome, which are the patients' condition and the underlying diseases, the surgical intervention and the anesthetic technique."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Adverse Cardiac Events', 'Adverse Effect of Unspecified General Anesthetic']}, 'descriptionModule': {'briefSummary': 'Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age more than 18, with acute limb ischemia undergoing revascularization procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 years\n* undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)\n\nExclusion Criteria:\n\n* incomplete data during perioperative period'}, 'identificationModule': {'nctId': 'NCT05362266', 'briefTitle': 'Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '052/2565'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Siriluk Suksri', 'role': 'CONTACT', 'phone': '+6624197990'}, {'name': 'Tachawan Jirativanont, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anesthesiology department, Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'MahidolU', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Tachawan Jirativanont, MD', 'role': 'CONTACT', 'email': 'tachawan.jir@mahidol.acth', 'phone': '+66816422817'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data has no plan for sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}