[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643948":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":67,"collaborators":12,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":12,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":12,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Helwan University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","this group receives only intravenous colistin therapy",null,{"label":14,"type":15,"description":16,"interventionNames":17},"alpha lipoic acid group","ACTIVE_COMPARATOR","this group receives oral alpha lipoic acid in addition to intravenous colistin therapy",[18],"Drug: alpha lipoic acid drug (thioctic acid acid)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","alpha lipoic acid drug (thioctic acid acid)","Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group.",[14],[26],{"name":27,"affiliation":28,"role":29},"Eman Magdy Elsayed Elyamany, Assistant lecturer","Faculty of pharmacy-Helwan university","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Eman Magy Elsayed Elyamany, Assistant lecturer","CONTACT","+201121051356","Iman.elyamany@pharm.capu.edu.eg",{"name":37,"role":33,"phone":38,"phoneExt":12,"email":39},"Mahmoud Ibrahim Mostafa, Lecturer","+201006605563","mahmoud.ibrahim@pharm.capu.edu.eg",[41,57],{"facility":42,"status":12,"city":43,"state":12,"zip":12,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"6th October Hospital-Dokki-General Authority for Health Insurance Organization","Giza","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],31.20861,30.00944,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":55,"phoneExt":12,"email":56},"Mohamed Taher Mohy Eldien, Vascular surgery consultant","+201272228188","mtm84mohy@gmail.com",{"facility":58,"status":12,"city":43,"state":12,"zip":12,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Al-Haram Hospital",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},[63],{"name":64,"role":33,"phone":65,"phoneExt":12,"email":66},"Ghada Abdelwahab Ali, Nephrology consultant","+201022610334","Ghadaabdeleahab@gmail.com",{"type":29,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Eman Magdy El-sayed El-yamany","Assistant lecturer at pharmacy practice department","100643948","phase-3-colistin-nephrotoxicity-and-role-of-alpha-lipoic-acid-100643948",false,"NCT07668141","Colistin Nephrotoxicity and Role of Alpha Lipoic Acid","Colistin Nephrotoxicity in Hospitalized Patients: The Role of Biomarkers in Guiding the Preventive Strategies","Inclusion Criteria:\n\n* Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria.\n* Patients who receive colistin for at least 3 days during their treatment.\n\nExclusion Criteria:\n\n* Patients who receive inhaled colistin.\n* Patients who had AKI at baseline\n* chronic kidney disease patients on regular hemodialysis.\n* Renal transplant patients\n* Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B.\n* Concurrent use of other antioxidants e.g. vitamin C, vitamin E and N-acetyl cysteine.\n* Patients are not willing to participate in the study.\n* Patients with any missed doses of colistin and or alpha-lipoic acid.\n* Patients with incomplete medical data\n* Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":81,"type":82},88,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. L.carnitine, vitamin C, vitamin E, N-acetyl cysteine, and alpha lipoic acid) in reducing the risk of colistin-induced nephrotoxicity but there is a lack of clinical studies on human. Due to the paucity of studies that early predict colistin-induced nephrotoxicity using early acute kidney injury \"AKI\" biomarkers e.g. kidney injury molecule 1\"KIM1\" and the lack of human studies that evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity, so this study will be conducted.",[88],"Nephrotoxicity",[90,91,92,88],"colistin","Alpa lipoic acid","kidney injury molecule-1","NOT_YET_RECRUITING","2026-06-19",{"date":96,"type":97},"2026-06-25","ACTUAL",{"date":99,"type":82},"2026-06-30",{"date":101,"type":82},"2027-02-28",{"name":5,"class":6},2]