{"id":"balanced-gelatine-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Hyperchloremic acidosis"},{"rate":null,"effect":"Coagulopathy"},{"rate":null,"effect":"Acute kidney injury"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Balanced gelatine solution is a plasma substitute composed of gelatine (a colloid derived from animal collagen) suspended in a balanced electrolyte solution. It expands intravascular volume and maintains oncotic pressure to counteract hypovolemia and maintain tissue perfusion. The balanced electrolyte composition helps maintain normal electrolyte concentrations during fluid resuscitation.","oneSentence":"Balanced gelatine solution provides fluid resuscitation and volume expansion by delivering a colloid suspension that maintains oncotic pressure and restores intravascular volume.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:42:54.725Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypovolemia and volume replacement during surgery and critical illness"},{"name":"Perioperative fluid resuscitation"}]},"trialDetails":[{"nctId":"NCT07172451","phase":"PHASE4","title":"Gelaspan vs Crystalloid Therapy in Sepsis","status":"RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2026-02-13","conditions":"Sepsis, Intra-Abdominal Infections","enrollment":318},{"nctId":"NCT02715466","phase":"PHASE4","title":"Gelatin in ICU and Sepsis","status":"TERMINATED","sponsor":"B. Braun Melsungen AG","startDate":"2016-04","conditions":"Hypovolemia","enrollment":167},{"nctId":"NCT04647396","phase":"NA","title":"Biomarker-guided Intervention to Prevent Acute Kidney Injury","status":"COMPLETED","sponsor":"University Hospital Muenster","startDate":"2020-11-17","conditions":"Acute Kidney Injury","enrollment":1180},{"nctId":"NCT05148650","phase":"NA","title":"Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers","status":"UNKNOWN","sponsor":"Medical University of Silesia","startDate":"2021-02-16","conditions":"Perioperative Hemorrhage, Dilutional Coagulopathy","enrollment":25},{"nctId":"NCT03244514","phase":"NA","title":"Biomarker-guided Implementation of the AKI Bundle","status":"COMPLETED","sponsor":"University Hospital Muenster","startDate":"2017-11-02","conditions":"Acute Kidney Injury (Nontraumatic)","enrollment":280},{"nctId":"NCT02808325","phase":"PHASE3","title":"Study on the Efficacy and Safety of Gelaspan","status":"COMPLETED","sponsor":"B. Braun Medical LLC","startDate":"2016-06","conditions":"Hypovolemia","enrollment":72},{"nctId":"NCT00520663","phase":"PHASE1","title":"Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-06-08","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":8},{"nctId":"NCT02782819","phase":"NA","title":"A Comparison of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation","status":"UNKNOWN","sponsor":"Mahidol University","startDate":"2014-09","conditions":"Hypotension and Shock","enrollment":320},{"nctId":"NCT02461329","phase":"NA","title":"Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy","status":"UNKNOWN","sponsor":"Kratochvil Milan, MD","startDate":"2015-05","conditions":"Hemorrhage, Surgical, Hip Replacement, Total, Thrombocytopathy","enrollment":50},{"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":"NCT01515397","phase":"PHASE3","title":"Comparison of Two Gelatine Solutions","status":"COMPLETED","sponsor":"B. Braun Melsungen AG","startDate":"2011-12","conditions":"Hypovolemia","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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 gelatine solution","genericName":"Balanced gelatine solution","companyName":"B. Braun Melsungen AG","companyId":"b-braun-melsungen-ag","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Balanced gelatine solution provides fluid resuscitation and volume expansion by delivering a colloid suspension that maintains oncotic pressure and restores intravascular volume. Used for Hypovolemia and volume replacement during surgery and critical illness, Perioperative fluid resuscitation.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}