{"id":"balanced-6-hydroxyethylstarch-130-0-4","safety":{"commonSideEffects":[{"rate":null,"effect":"Increased bleeding/coagulopathy"},{"rate":null,"effect":"Acute kidney injury"},{"rate":null,"effect":"Hyperchloremic acidosis"},{"rate":"rare","effect":"Anaphylactic reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hydroxyethylstarch (HES) is a large polysaccharide polymer that remains in the intravascular space longer than crystalloid solutions, providing sustained volume expansion and maintaining colloid osmotic pressure. The 130/0.4 designation refers to the mean molecular weight (130 kDa) and degree of substitution (0.4), which determine its pharmacokinetic profile. The balanced formulation contains electrolytes in physiologic proportions to reduce hyperchloremic acidosis associated with older HES products.","oneSentence":"Balanced 6% hydroxyethylstarch 130/0.4 is a synthetic colloid that expands intravascular volume by maintaining oncotic pressure in the bloodstream.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:42:54.706Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fluid resuscitation and volume replacement in acute blood loss during surgery or trauma"},{"name":"Perioperative volume management in patients requiring colloid support"}]},"trialDetails":[{"nctId":"NCT07410988","phase":"PHASE4","title":"Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications","status":"NOT_YET_RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2026-04-01","conditions":"Cardiac Surgery","enrollment":1292},{"nctId":"NCT02584868","phase":"PHASE3","title":"Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid","status":"COMPLETED","sponsor":"Queen Fabiola Children's University Hospital","startDate":"2013-02-15","conditions":"Cardiac Surgery, Cardiopulmonary Bypass","enrollment":88},{"nctId":"NCT03222778","phase":"","title":"Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2017-12-01","conditions":"Fluid Responsiveness","enrollment":66},{"nctId":"NCT01303250","phase":"PHASE4","title":"Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery","status":"TERMINATED","sponsor":"University Hospital Muenster","startDate":"2011-04","conditions":"Surgery, Colorectal","enrollment":31},{"nctId":"NCT01874730","phase":"NA","title":"KOREAN Enhanced RecOvery Strategy for Colorectal Surgery","status":"TERMINATED","sponsor":"Duke University","startDate":"2013-07","conditions":"Goal-oriented Fluid Therapy, Colorectal Surgery","enrollment":101},{"nctId":"NCT02034682","phase":"NA","title":"The Effect of Hydroxyethylstarch 6% 130/0.4 in a Balanced Electrolyte Solution (Volulyte®) Compared to Gelatine (Geloplasma®) on Microvascular Reactivity and Tissue Oxygen Saturation During Haemodilution Measured With Near-infrared Spectroscopy","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2014-01","conditions":"Microvascular Reactivity, Tissue Oxygen Saturation","enrollment":40},{"nctId":"NCT01670604","phase":"PHASE4","title":"Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures","status":"UNKNOWN","sponsor":"Kasr El Aini Hospital","startDate":"2012-01","conditions":"Urologic Surgical Procedures","enrollment":40},{"nctId":"NCT00962156","phase":"PHASE3","title":"Scandinavian Starch for Severe Sepsis/Septic Shock Trial","status":"COMPLETED","sponsor":"Anders Perner","startDate":"2009-12","conditions":"Severe Sepsis, Septic Shock","enrollment":804},{"nctId":"NCT01301469","phase":"PHASE3","title":"Comparison of HES 130 in Balanced and in Unbalanced Solution","status":"COMPLETED","sponsor":"B. Braun Melsungen AG","startDate":"2011-02","conditions":"Decreased and Nonspecific Blood Pressure Disorders and Shock","enrollment":240},{"nctId":"NCT01012648","phase":"PHASE4","title":"Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury","status":"UNKNOWN","sponsor":"University of Zurich","startDate":"2009-11","conditions":"Burns","enrollment":48},{"nctId":"NCT00576849","phase":"PHASE4","title":"A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients","status":"COMPLETED","sponsor":"Klinikum Ludwigshafen","startDate":"2007-12","conditions":"Elderly, Cardiac Surgery","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"balanced 6% hydroxyethylstarch 130/0.4","genericName":"balanced 6% hydroxyethylstarch 130/0.4","companyName":"University Hospital Muenster","companyId":"university-hospital-muenster","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Balanced 6% hydroxyethylstarch 130/0.4 is a synthetic colloid that expands intravascular volume by maintaining oncotic pressure in the bloodstream. Used for Fluid resuscitation and volume replacement in acute blood loss during surgery or trauma, Perioperative volume management in patients requiring colloid support.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}