[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558849":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous terlipressin infusion + Norepinephrine","EXPERIMENTAL","1. Patients in this group will receive continuous terlipressin infusion (1 mg\u002F24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg\u002F24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively.\n2. Norepinephrine will be initiated @0.05mcg\u002Fkg\u002Fmin and titrated upto 0.5 mcg\u002Fkg\u002Fmin to maintain a MAP \\> 65 to 75 mm Hg.\n3. IV albumin as per volume status to maintain target MAP .\n4. If the target MAP is not achieved, a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine.",[13,14],"Drug: Terlipressin","Drug: Norephrine",{"label":16,"type":17,"description":18,"interventionNames":19},"Norepinephrine","ACTIVE_COMPARATOR","1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg\u002Fkg\u002Fmin to 0.5 mcg\u002Fkg\u002Fmin to maintain a MAP \\> 65 to 75 mm Hg.\n2. IV albumin as per volume status to maintain target MAP .\n3. If the target MAP is not achieved, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Terlipressin","1\\. Patients in this group will receive continuous terlipressin infusion (1 mg\u002F24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg\u002F24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Norephrine","1\\. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg\u002Fkg\u002Fmin to 0.5 mcg\u002Fkg\u002Fmin to maintain a MAP \\> 65 to 75 mm Hg.",[9,16],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dr Jitendra Kumar Singh, MD","CONTACT","01146300000","jitendra2602kc@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Institute of Liver & Biliary Sciences (ILBS)","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":46,"coordinates":47},"Point",[48,49],77.2148,28.62137,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100558849","safety-and-efficacy-of-continuous-infusion-of-terlipressin-with-norepinephrine-versus-norepinephrine-alone-in-improving-outcomes-of-acute-kidney-injury-in-acute-on-chronic-liver-failure-with-septic-shock-100558849",false,"NCT06556472","Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock","Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial","Inclusion Criteria:\n\n1. Age\\>18 years and \\\u003C60 yrs\n2. ACLF as per APASL\n3. AKI according to KDIGO Criteria\n4. septic shock requiring norepinephrine (\\\u003C0.05mcg\u002Fkg\u002Fmin).\n\nExclusion Criteria:\n\n1. Septic shock requiring 2 vasopressors (Norephinephrine reuirement \\> 0.05mcg\u002Fkg\u002Fmin)\n2. Symptomatic cardiopulmonary disease\n3. Chronic kidney disease\n4. Peripheral vascular disease\n5. Hepatocellular carcinoma outside Milan criteria\n6. Prior use of terlipressin in last 48 hours\n7. Patients with hypovolemic or hemorrhagic shock\n8. Patients already meeting criteria for dialysis or with history of dialysis in last 7 days\n9. Intrinsic kidney disease, Acute tubular necrosis with urinary output \\\u003C 400 ml \u002Fday or obstructive uropathy\n10. History of immunosuppressive drugs\n11. Pregnancy\n12. Human immunodeficiency virus 1 and 2\n13. Portal vein thrombus","ALL","18 Years","60 Years",{"count":66,"type":67},126,"ESTIMATED","INTERVENTIONAL",[70],"NA","ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg\u002FdL (85 micromol\u002FL) and coagulopathy (INR ≥ 1.5 or prothrombin activity \\\u003C 40%) complicated within 4 weeks by clinical ascites and\u002For encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease\u002Fcirrhosis, and is associated with a high 28-day mortality.\n\nAt the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.\n\nCurrently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.\n\nDevelopment of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.",[73],"Acute on Chronic Liver Failure","NOT_YET_RECRUITING","2024-08-13",{"date":77,"type":78},"2024-08-16","ACTUAL",{"date":80,"type":67},"2024-08-15",{"date":82,"type":67},"2025-08-31",{"name":5,"class":6},1]