Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04768751
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2021-02-20', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development myocardial injury', 'timeFrame': 'through study completion, an average of 15 days', 'description': 'New echocardiographic findings suggestive of ischemia (new regional wall motion abnormalities) or cardiac troponin T \\>.0.32 ng/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Ventricular Dysfunction', 'Myocardium; Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .\n\nAcute kidney injury is associated with significantly increased resource utilization and health care costs.\n\nMajor adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with normal kidney functions and free normal heart functions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with normal kidney functions and free normal heart functions, were enrolled to this study\n\nExclusion Criteria:\n\n* patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04768751', 'briefTitle': 'Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Systolic Dysfunction After Non-Cardiac Surgery in Critical Patients', 'orgStudyIdInfo': {'id': 'Acute Kidney injury'}}, 'armsInterventionsModule': {'interventions': [{'name': 'kidney assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urea, BUN, and Creatinine BLOOD LEVELS'}]}, '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': '4- Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt', 'investigatorFullName': 'Alaa Ali M. Elzohry', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}