Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-30 @ 8:48 PM
Study NCT ID:
NCT06775158
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2025-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-04', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area under the curve of receiver operating characteristics curve generated by using intraoperative Lactate, base excess, venous saturation and delta carbondioxide pressure', 'timeFrame': '3 days postoperatively', 'description': 'intraoperative labaratory parameters obtained by arterai blood gas analysis will be evaluated by creating a model with logistic regression'}], 'primaryOutcomes': [{'measure': 'Number of patients sufferd from Acute Kidney injury', 'timeFrame': '3 days postoperatively', 'description': 'at least 0.3mg/dL or 50% increase from baseline creatinine levels within 3 days postoperatively is described as Acute Kidney İnjury. Data will be presented as frequency(percentage) and the margin error of the percentage'}, {'measure': 'Number of patients suffered from Perioperative myocardial injury', 'timeFrame': '3 days postoperatively', 'description': 'At least 14 ng/L increase from baseline high sensitive Troponin T levels within 3 days psotoperatively is described as perioperative myocardial injury. Data will be presented as frequency(percentage) and the margin error of the percentage'}, {'measure': 'Number of patients suffered from perioperative organ injury', 'timeFrame': '3 days postoperatively', 'description': "Occurence of acute kidney injury or perioperative myocardial injury within 3 days in patients undergoing hepatic resection. Descriptions are clarified in the prior outcomes' description sections. Data will be presented as frequency(percentage) and the margin error of the percentage"}, {'measure': 'Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury', 'timeFrame': '3 days postoperatively', 'description': "Patients' demographic, medical and intraoperative characteristics will be evaluated in terms of the occurence of perioperative organ injury. Variables with the p value \\< 0,05 will be added to the logistic regression model."}], 'secondaryOutcomes': [{'measure': 'Length of intensive care unit stay', 'timeFrame': '90 days postoperatively', 'description': 'Length of intensive care unit stay during postoperative period will be evaluated in patients who did and did not suffer from perioperative organ injury'}, {'measure': 'Length of hospital stay', 'timeFrame': '90 days postoperatively', 'description': 'Length of hospital stay in the postoperative period, including intensive care will be evaluated in patients who did and did not suffer from perioperative organ injury'}, {'measure': '90-day mortality', 'timeFrame': '90 days postoperatively', 'description': '90-day mortality following the surgery will be evaluated in patients who did and did not suffer from perioperative organ injury'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic resection', 'acute kidney injury', 'perioperative myocardial injury'], 'conditions': ['Liver Neoplasm', 'Kidney Injury, Acute', 'Myocardial Injury After Non-Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes.', 'detailedDescription': 'Hepatic resections are highly invasive major surgical procedures and are associated with higher incidence of end-organ injuries, specifically acute kidney injury (AKI) and perioperative myocardial injury (PMI). This study was designed to determine the incidences of AKI and PMI, and reveal the risk factors for their development and investigate intraoperative labaratory predictors in patients undergoing hepatic resection. We also planned to evaluate the relationship between the occurrence of end-organ injury and length of hospital and intensive care unit (ICU) stay, and 90-day mortality.\n\nPatients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent resection in Hepatobiliary\\&Pancreatic Surgery Clinic of Başakşehir Çam\\&Sakura City Hospital, between june 2021 and june 2024', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent hepatic resection\n\nExclusion Criteria:\n\n* presence of end stage kidney disease\n* emergency surgery\n* application of total vascular exclusion\n* concomitant gastrointestinal resection\n* duration of surgery less than 100 minutes\n* non-oncologic procedures'}, 'identificationModule': {'nctId': 'NCT06775158', 'briefTitle': 'Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Saglik Bilimleri University'}, 'officialTitle': 'Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection: Incidence, Risk Factors, Predictors and Relation with Patient Outcomes: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '27..2024.297'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with organ injury', 'description': 'Patitents who suffered from AKI or PMI'}, {'label': 'Patients without organ injury', 'description': 'Patitents who did not suffer from AKI or PMI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34480', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Başakşehir Çam&Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All raw data that will be used during the statitistical analysis will be shared by the primary investigator upon reosanable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Saglik Bilimleri University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Anesthesiology and Reanimation', 'investigatorFullName': 'Taner Abdullah', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}