Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04165369
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2019-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-16', 'size': 1128433, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-18T03:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10568}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury', 'timeFrame': '72 hours after extended surgery', 'description': 'Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria'}], 'secondaryOutcomes': [{'measure': 'Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)', 'timeFrame': '72 hours after extended surgery', 'description': 'Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury'}, {'measure': 'Number of patients with renal replacement therapy', 'timeFrame': 'up to 90 days after extended surgery'}, {'measure': 'Mortality', 'timeFrame': 'up to 90 days after extended surgery'}, {'measure': 'Hospital stay', 'timeFrame': 'up to 90 days after extended surgery (until discharge)'}, {'measure': 'Intensive Care Unit stay', 'timeFrame': 'up to 90 days after extended surgery (until discharge)'}, {'measure': 'Major Adverse Kidney Events (MAKE)', 'timeFrame': 'up to 90 days after extended surgery', 'description': 'combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine \\>= 1.5 times as compared to baseline serum-creatinine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'injury', 'surgery'], 'conditions': ['Acute Kidney Injury (AKI)']}, 'referencesModule': {'references': [{'pmid': '38285051', 'type': 'DERIVED', 'citation': 'Meersch M, Weiss R, Strauss C, Albert F, Booke H, Forni L, Pittet JF, Kellum JA, Rosner M, Mehta R, Bellomo R, Rosenberger P, Zarbock A; EPIS-AKI Investigators. Acute kidney disease beyond day 7 after major surgery: a secondary analysis of the EPIS-AKI trial. Intensive Care Med. 2024 Feb;50(2):247-257. doi: 10.1007/s00134-023-07314-2. Epub 2024 Jan 29.'}, {'pmid': '37505258', 'type': 'DERIVED', 'citation': 'Zarbock A, Weiss R, Albert F, Rutledge K, Kellum JA, Bellomo R, Grigoryev E, Candela-Toha AM, Demir ZA, Legros V, Rosenberger P, Galan Menendez P, Garcia Alvarez M, Peng K, Leger M, Khalel W, Orhan-Sungur M, Meersch M; EPIS-AKI Investigators. Epidemiology of surgery associated acute kidney injury (EPIS-AKI): a prospective international observational multi-center clinical study. Intensive Care Med. 2023 Dec;49(12):1441-1455. doi: 10.1007/s00134-023-07169-7. Epub 2023 Jul 28.'}, {'pmid': '35588372', 'type': 'DERIVED', 'citation': 'Weiss R, Saadat-Gilani K, Kerschke L, Wempe C, Meersch M, Zarbock A; EPIS-AKI Investigators. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial. BMJ Open. 2021 Dec 30;11(12):e055705. doi: 10.1136/bmjopen-2021-055705.'}]}, 'descriptionModule': {'briefSummary': 'The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.\n\nThe primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.', 'detailedDescription': 'Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI.\n\nThe primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors.\n\nMethod: International prospective, observational, multi-center, cross-sectional cohort study\n\nEligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing extended surgical procedure and the need for postoperative observation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major elective or emergency surgery procedures with a duration of at least 2 h\n* admission to the intensive care unit, intermediate care unit after surgery informed consent\n\nExclusion Criteria:\n\n* preexisting acute kidney injury\n* acute kidney injury within the last 3 months\n* end stage renal disease with dialysis dependency\n* kidney transplant'}, 'identificationModule': {'nctId': 'NCT04165369', 'acronym': 'Epis-AKI', 'briefTitle': 'Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury', 'orgStudyIdInfo': {'id': '01-AnIt-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with extended surgical exposures', 'description': 'Patients with extended surgical exposures requiring postoperative observation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University Faculty of Medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 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