Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT05068167
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2021-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007677', 'term': 'Kidney Function Tests'}], 'ancestors': [{'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinine level', 'timeFrame': 'every 12 hours', 'description': 'Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury (AKI)']}, 'descriptionModule': {'briefSummary': 'The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease. A better understanding of the mechanism of this hypthesis will lead to better management of this complication.', 'detailedDescription': 'A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who were candidates for major surgery in the Cancer Institute of South Egypt, Assiut University, Egypt. Patients excluded from this study were patients with chronic cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy, chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who were candidates for major non cardiac surgery\n\nExclusion Criteria:\n\n* chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT05068167', 'briefTitle': 'Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients', 'orgStudyIdInfo': {'id': 'ACI after non cardiac surgery'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Kidney function test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours'}]}, 'contactsLocationsModule': {'locations': [{'zip': '+2071516', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Alaa Ali Elzohry', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Egypt Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt', 'investigatorFullName': 'Alaa Ali M. Elzohry', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}