{"id":"custodiol-htk","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Custodiol HTK (histidine-tryptophan-ketoglutarate solution) is a specialized preservation medium designed to protect donor organs during the cold storage period before transplantation. It maintains intracellular electrolyte balance, reduces cellular edema, and provides metabolic support to minimize reperfusion injury and extend organ viability time compared to standard preservation solutions.","oneSentence":"Custodiol HTK is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing a balanced electrolyte composition and metabolic substrates.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:13.093Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation"}]},"trialDetails":[{"nctId":"NCT07205757","phase":"PHASE4","title":"Adding Lidocaine to Custodiol Mixture","status":"RECRUITING","sponsor":"Fayoum University Hospital","startDate":"2025-10-03","conditions":"CAD, Arrhythmia Ventricular","enrollment":70},{"nctId":"NCT03627013","phase":"PHASE3","title":"Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)","status":"RECRUITING","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2019-05-23","conditions":"Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure","enrollment":362},{"nctId":"NCT06530641","phase":"PHASE4","title":"Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.","status":"RECRUITING","sponsor":"Lourdes Montero Cruces","startDate":"2024-12-01","conditions":"Cardiac Surgery, Cardioplegia, Heart Arrest","enrollment":600},{"nctId":"NCT03082716","phase":"PHASE2","title":"Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery","status":"COMPLETED","sponsor":"King Faisal Specialist Hospital & Research Center","startDate":"2016-03-16","conditions":"Congenital Heart Disease","enrollment":49},{"nctId":"NCT05031052","phase":"NA","title":"Normothermic Machine Perfusion (NMP) Versus Static Cold Storage (SCS) in Human Kidney Transplantation","status":"UNKNOWN","sponsor":"Charite University, Berlin, Germany","startDate":"2022-05-10","conditions":"Kidney Transplant; Complications, Kidney Failure, Graft Dysfunction","enrollment":194},{"nctId":"NCT01681095","phase":"PHASE2","title":"Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent","status":"COMPLETED","sponsor":"Marc Sakwa, MD","startDate":"2012-08","conditions":"Coronary Artery Disease, Myocardial Ischemia, Coronary Disease","enrollment":110},{"nctId":"NCT01564095","phase":"PHASE2, PHASE3","title":"TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion","status":"TERMINATED","sponsor":"Ludwig-Maximilians - University of Munich","startDate":"2011-10","conditions":"Terminal Liver Disease, Ischemia Reperfusion Injury, Graft Dysfunction","enrollment":25},{"nctId":"NCT01887171","phase":"NA","title":"Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus","status":"COMPLETED","sponsor":"Republican Scientific and Practical Center for Organ and Tissue Transplantation","startDate":"2013-07","conditions":"Early Allograft Dysfunction, Ischemic Reperfusion Injury, Liver Transplantation","enrollment":86},{"nctId":"NCT01614951","phase":"PHASE4","title":"The Pulmonary Protection Trial","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2012-07","conditions":"Chronic Obstructive Lung Disease","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":36,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Histidine-tryptophan-ketoglutarate cardioplegia solution"],"phase":"phase_3","status":"active","brandName":"Custodiol HTK","genericName":"Custodiol HTK","companyName":"Marc Sakwa, MD","companyId":"marc-sakwa-md","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Custodiol HTK is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing a balanced electrolyte composition and metabolic substrates. Used for Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}