Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-03 @ 2:33 AM
Study NCT ID:
NCT06341933
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2024-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], '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': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular Filtration Rate', 'timeFrame': '1 day', 'description': "Glomerular filtration rate (GFR) is the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time."}, {'measure': 'Serum Creatinine', 'timeFrame': '1 day', 'description': 'The creatinine blood test measures the level of creatinine in the blood. This test is done to see how well your kidneys are working. Creatinine in the urine can be measured with a urine test. A measurement of the serum creatinine level is often used to evaluate kidney function.'}, {'measure': 'Amount of Urine', 'timeFrame': '1 day', 'description': "The amount of urine produced per hour according to the patient's weight"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Lung Cancer', 'Video Assisted Thoracoscopic Surgery'], 'conditions': ['Acute Kidney Injury', 'Surgery', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.\n\nThe research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.\n\nPatients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.\n\nThe preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Based on the given parameters of a 1/3 patient ratio, two-sided (two-tailed) type I error of 0.05, power of 95%, effect size of 0.86, and group distribution ratio of 3, it was determined that the group with acute kidney injury should include 24 patients and the group without acute kidney injury should include 72 patients. Our study was designed to include an average of 100 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age, under 65 years of age,\n* American Society of Anesthesiologists (ASA) physical status 1-3,\n* Data of patients who will undergo wedge resection, segmentectomy or lobectomy with elective VATS due to lung malignancy will be examined prospectively.\n\nExclusion Criteria:\n\n* Patients with a body mass index (BMI) less than 18.5kg/m2 or greater than 35 kg/m2,\n* Those with impaired renal function (the upper limit of the creatinine reference range is more than 50%; 1.3 mg/dL for men and 1.1 mg/dL for women),\n* A radiological examination was performed using radiocontrast material in the preoperative period,\n* Clinically and radiologically diagnosed with congestive heart failure and treatment has been started,\n* Having a history of pulmonary edema,\n* Those who have used steroids and non-steroidal anti-inflammatory drugs for a long time (exceeding 30 days),\n* Intubated to intensive care unit,\n* In need of massive peroperative blood transfusion,\n* Patients with deficiencies in the parameters examined will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06341933', 'briefTitle': 'Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection', 'organization': {'class': 'OTHER', 'fullName': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '2024-BÇEK/41'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Kidney Injury (NO)', 'description': 'In the postoperative period, patients with normal renal function.', 'interventionNames': ['Other: Duration of Surgery', 'Other: Volume of Fluid in Surgery', 'Other: Blood Loss']}, {'label': 'Acute Kidney Injury (YES)', 'description': 'There has been a decrease of more than 25% in the estimated glomerular filtration rate (t-GFH), and/or a 1.5-fold increase in serum creatinine, and/or a 6-hour urine volume of less than 0.5 ml/kg/h.', 'interventionNames': ['Other: Duration of Surgery', 'Other: Volume of Fluid in Surgery', 'Other: Blood Loss']}], 'interventions': [{'name': 'Duration of Surgery', 'type': 'OTHER', 'description': 'Total surgery time in minutes', 'armGroupLabels': ['Acute Kidney Injury (NO)', 'Acute Kidney Injury (YES)']}, {'name': 'Volume of Fluid in Surgery', 'type': 'OTHER', 'description': 'Fluid volume given during surgery in ml', 'armGroupLabels': ['Acute Kidney Injury (NO)', 'Acute Kidney Injury (YES)']}, {'name': 'Blood Loss', 'type': 'OTHER', 'description': 'Blood loss during surgery in ml', 'armGroupLabels': ['Acute Kidney Injury (NO)', 'Acute Kidney Injury (YES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06290', 'city': 'Ankara', 'state': 'Keçiören', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali ALAGÖZ, professor', 'role': 'CONTACT', 'email': 'mdalagoz@gmail.com', 'phone': '5079193765', 'phoneExt': '+9'}, {'name': 'Fatma ÖZTÜRK YALÇIN, specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Onur KÜÇÜK, specialist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara Atatürk Sanatorium Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ali ALAGÖZ, professor', 'role': 'CONTACT', 'email': 'mdalagoz@gmail.com', 'phone': '5079193765', 'phoneExt': '+9'}], 'overallOfficials': [{'name': 'Ali ALAGÖZ, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Ataturk Sanatorium Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor', 'investigatorFullName': 'Ali Alagoz', 'investigatorAffiliation': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}}}}