Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-11 @ 5:26 AM
Study NCT ID:
NCT02113150
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2014-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2014-03-23', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GFR value', 'timeFrame': '2 months'}], 'primaryOutcomes': [{'measure': 'creatinin, BUN', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Cystatin-c level', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['troponin t,cystatin-c,ketamine,remifentanil'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'In this prospective, randomized, clinical trial, we have investigated the effects of ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney injury in CABG surgery.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Patients scheduled for elective CABG with cardiopulmonary bypass. Patients were randomly allocated to anesthesia with remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group. Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1, 2, and 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients undergoing elective CABG with cardiopulmonary bypass\n\nExclusion Criteria:\n\npatients undergoing emergency operation, combined operation, off-pump surgery, repeat surgery or valve surgery, patients presenting with chronic kidney disease or renal impairment, patients younger than 18 years old and neurological and/or psychiatric disturbances.'}, 'identificationModule': {'nctId': 'NCT02113150', 'briefTitle': 'A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery', 'orgStudyIdInfo': {'id': 'TurkiyeYIH'}, 'secondaryIdInfos': [{'id': 'Zaslidem', 'type': 'REGISTRY', 'domain': 'aslı demir'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil', 'description': 'remifentanil, short acting opioid', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine', 'description': 'ketamine, intravenous anesthetic', 'interventionNames': ['Drug: remifentanil']}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'renal function', 'armGroupLabels': ['ketamine']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['ketalar'], 'description': 'renal function', 'armGroupLabels': ['remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Aslı Demir', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06550', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Turkey Yuksek Ihtisas Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aslı Demir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turkey Yuksek Ihtisas Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkiye Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Z.Aslı Demir, MD, Assoc.Prof', 'investigatorFullName': 'aslı demir', 'investigatorAffiliation': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}}}}