drugset / Trial / NCT02015403

To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed

NCT02015403

RandomizedParallel-groupOpen-labelTreatment

Summary

Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours GROUP B : 110 Patients will receive standard care only NAC will be given at following rate : Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs

Timeline

Start
2013-12
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 6.25 mg/kg Intravenous

Indications