{"id":"hypertonic-lactate","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperchloremic acidosis"},{"rate":null,"effect":"Hypernatremia"},{"rate":null,"effect":"Phlebitis at infusion site"},{"rate":null,"effect":"Rebound intracranial hypertension"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hypertonic lactate acts as both an osmotic agent and a readily metabolizable fuel source. It helps restore intracellular ATP production, reduce cerebral edema, and improve microcirculatory perfusion in conditions of shock or severe tissue hypoxia. The lactate is oxidized by mitochondria to generate energy while the hypertonic solution draws fluid from the interstitial space, reducing intracranial pressure.","oneSentence":"Hypertonic lactate provides osmotic support and metabolic substrate to restore cellular energy and reduce intracranial pressure in critically ill patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:47:54.530Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Resuscitation in hemorrhagic shock and trauma"},{"name":"Cerebral edema and elevated intracranial pressure"},{"name":"Septic shock and severe metabolic acidosis"}]},"trialDetails":[{"nctId":"NCT05004610","phase":"PHASE2","title":"Hypertonic Lactate After Cardiac Arrest","status":"RECRUITING","sponsor":"Erasme University Hospital","startDate":"2025-02-19","conditions":"Cardiac Arrest, Ischemia Reperfusion Injury, Anoxic Brain Injury","enrollment":125},{"nctId":"NCT06370975","phase":"PHASE1, PHASE2","title":"Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2024-08-01","conditions":"Fluid Resuscitation","enrollment":150},{"nctId":"NCT06110429","phase":"PHASE3","title":"Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients","status":"UNKNOWN","sponsor":"University Hospital, Geneva","startDate":"2024-01","conditions":"Intra Cerebral Hypertension, Lactate Sodium Solution","enrollment":52},{"nctId":"NCT04488874","phase":"PHASE3","title":"Sodium Lactate and Brain Relaxation (LSD)","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2020-09-29","conditions":"Sodium Lactate, Intracranial Hypertension, Brain Relaxation","enrollment":50},{"nctId":"NCT05810662","phase":"NA","title":"RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH","status":"UNKNOWN","sponsor":"National Cancer Institute, Egypt","startDate":"2022-09-04","conditions":"Fluid and Electrolyte Imbalance","enrollment":60},{"nctId":"NCT00113685","phase":"NA","title":"Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury","status":"COMPLETED","sponsor":"University of Washington","startDate":"2003-04","conditions":"Respiratory Distress Syndrome, Adult, Head Injuries, Closed, Shock","enrollment":209},{"nctId":"NCT02782520","phase":"PHASE3","title":"Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery","status":"COMPLETED","sponsor":"University Hospital, Grenoble","startDate":"2016-08","conditions":"Right Ventricular Impaired Function, Hypovolemia","enrollment":30},{"nctId":"NCT01428050","phase":"PHASE2","title":"The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy","status":"UNKNOWN","sponsor":"Thomas Jefferson University","startDate":"2011-05","conditions":"Pancreaticoduodenectomy","enrollment":264},{"nctId":"NCT00318942","phase":"PHASE3","title":"Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients","status":"COMPLETED","sponsor":"University of Versailles","startDate":"2003-02","conditions":"Critical Illness","enrollment":2857},{"nctId":"NCT01654653","phase":"PHASE4","title":"Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients","status":"COMPLETED","sponsor":"Innogene Kalbiotech Pte. Ltd","startDate":"2008-07","conditions":"Coronary Heart Disease","enrollment":100},{"nctId":"NCT01433276","phase":"PHASE3","title":"Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock","status":"COMPLETED","sponsor":"Innogene Kalbiotech Pte. Ltd","startDate":"2009-07","conditions":"Hemorrhagic Shock","enrollment":71},{"nctId":"NCT00966628","phase":"PHASE3","title":"Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients (DSS)","status":"UNKNOWN","sponsor":"Innogene Kalbiotech Pte. Ltd","startDate":"2008-05","conditions":"Dengue Shock Syndrome","enrollment":50},{"nctId":"NCT00529490","phase":"PHASE3","title":"Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats","status":"COMPLETED","sponsor":"Innogene Kalbiotech Pte. Ltd","startDate":"2002-03","conditions":"Low Cardiac Output","enrollment":230},{"nctId":"NCT00529711","phase":"PHASE3","title":"The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients","status":"COMPLETED","sponsor":"Innogene Kalbiotech Pte. Ltd","startDate":"2005-07","conditions":"Low Cardiac Output","enrollment":66}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Totilac","Totilac™"],"phase":"marketed","status":"active","brandName":"Hypertonic lactate","genericName":"Hypertonic lactate","companyName":"Innogene Kalbiotech Pte. Ltd","companyId":"innogene-kalbiotech-pte-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Hypertonic lactate provides osmotic support and metabolic substrate to restore cellular energy and reduce intracranial pressure in critically ill patients. Used for Hypovolemic shock and hemorrhagic shock, Traumatic brain injury with elevated intracranial pressure, Septic shock with tissue hypoperfusion.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}